Seguridad y eficacia de lenvatinib (E7080/MK-7902) con pembrolizumab (MK-3475) en combinación con quimioembolización transarterial (TACE) en participantes con carcinoma hepatocelular incurable/no metastásico (MK-7902-012/E7080-G000-318/ SALTO-012)
1 de septiembre de 2026 actualizado por: Merck Sharp & Dohme LLC
Estudio clínico de fase 3, multicéntrico, aleatorizado, doble ciego, con control activo para evaluar la seguridad y la eficacia de lenvatinib (E7080/MK-7902) con pembrolizumab (MK-3475) en combinación con quimioembolización transarterial (TACE) frente a TACE en Participantes con carcinoma hepatocelular incurable/no metastásico (LEAP-012)
El propósito de este estudio es evaluar la eficacia y seguridad de lenvatinib y pembrolizumab en combinación con TACE versus TACE más placebos orales e intravenosos (IV) en participantes con carcinoma hepatocelular (HCC) no metastásico incurable.
Las hipótesis principales son que pembrolizumab más lenvatinib en combinación con TACE es superior al placebo más TACE con respecto a la supervivencia libre de progresión (PFS) y la supervivencia general (OS).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
480
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Berlin, Alemania, 13353
- Charite - Universitaetsmedizin ( Site 0204)
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Hamburg, Alemania, 20246
- Universitaetsklinikum Hamburg-Eppendorf ( Site 0207)
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Baden-Wurttemberg
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Freiburg im Breisgau, Baden-Wurttemberg, Alemania, 79106
- Universitaetsklinikum Freiburg ( Site 0199)
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Hesse
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Frankfurt am Main, Hesse, Alemania, 60488
- Krankenhaus Nord-West GmbH ( Site 0208)
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Lower Saxony
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Hanover, Lower Saxony, Alemania, 30625
- Medizinische Hochschule Hannover ( Site 0200)
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North Rhine-Westphalia
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Bonn, North Rhine-Westphalia, Alemania, 53127
- Universitaetsklinikum Bonn ( Site 0203)
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Saxony
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Leipzig, Saxony, Alemania, 04103
- Universitaetsklinikum Leipzig ( Site 0202)
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Saxony-Anhalt
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Halle, Saxony-Anhalt, Alemania, 06120
- Universitaetsklinikum Halle ( Site 0213)
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Schleswig-Holstein
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Lübeck, Schleswig-Holstein, Alemania, 23538
- Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0215)
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New South Wales
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Kogarah, New South Wales, Australia, 2217
- St George Hospital ( Site 0005)
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Westmead, New South Wales, Australia, 2145
- Westmead Hospital-Gastroenterology & Hepatology ( Site 0009)
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Queensland
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Brisbane, Queensland, Australia, 4102
- Princess Alexandra Hospital ( Site 0006)
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Victoria
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Heidelberg, Victoria, Australia, 3084
- Austin Health ( Site 0008)
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Melbourne, Victoria, Australia, 3004
- Alfred Health ( Site 0004)
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Western Australia
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Perth, Western Australia, Australia, 6000
- Royal Perth Hospital ( Site 0002)
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São Paulo, Brasil, 01509-900
- A.C. Camargo Cancer Center ( Site 0054)
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Rio Grande do Norte
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Natal, Rio Grande do Norte, Brasil, 59075-740
- Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0057)
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasil, 91350-200
- Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0056)
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Santa Catarina
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Blumenau, Santa Catarina, Brasil, 89010-340
- Clinica de Oncologia Reichow ( Site 0052)
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São Paulo
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Barretos, São Paulo, Brasil, 14784-400
- Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 0058)
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Jaú, São Paulo, Brasil, 17210-120
- Fundacao Dr Amaral Carvalho ( Site 0050)
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São José do Rio Preto, São Paulo, Brasil, 15090-000
- Hospital de Base de Sao Jose de Rio Preto ( Site 0043)
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São Paulo, São Paulo, Brasil, 01323-001
- BP - A Beneficencia Portuguesa de São Paulo ( Site 0046)
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Araucania
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Temuco, Araucania, Chile, 4800827
- Centro Investigación del Cáncer James Lind ( Site 0064)
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Region M. de Santiago
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Santiago, Region M. de Santiago, Chile, 7560908
- Centro de Oncología de Precisión-Oncology ( Site 0068)
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Santiago, Region M. de Santiago, Chile, 8330024
- Centro de Cancer Nuestra Senora de la Esperanza ( Site 0065)
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Santiago, Region M. de Santiago, Chile, 8420383
- Bradfordhill ( Site 0066)
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Antioquia
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Medellín, Antioquia, Colombia, 050034
- Hospital Pablo Tobon Uribe ( Site 0145)
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Bogota D.C.
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Bogotá, Bogota D.C., Colombia, 110221
- Administradora Country S.A. ( Site 0137)
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Santander Department
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Piedecuesta, Santander Department, Colombia, 681017
- Fundacion Cardiovascular de Colombia ( Site 0136)
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Valle del Cauca Department
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Cali, Valle del Cauca Department, Colombia, 760032
- Fundación Valle del Lili ( Site 0140)
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Seoul, Corea del Sur, 03080
- Seoul National University Hospital ( Site 0567)
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Seoul, Corea del Sur, 03722
- Severance Hospital Yonsei University Health System ( Site 0564)
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Seoul, Corea del Sur, 05505
- Asan Medical Center ( Site 0565)
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Seoul, Corea del Sur, 06351
- Samsung Medical Center ( Site 0566)
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Seoul, Corea del Sur, 06591
- The Catholic University of Korea St. Mary s Hospital ( Site 0571)
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Seoul, Corea del Sur, 08308
- Korea University Guro Hospital ( Site 0573)
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Jeonranamdo
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Hwasun, Jeonranamdo, Corea del Sur, 58128
- Chonnam National University Hwasun Hospital ( Site 0572)
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Kyonggi-do
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Seongnam-si, Kyonggi-do, Corea del Sur, 13620
- Seoul National University Bundang Hospital ( Site 0570)
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Pusan-Kwangyokshi
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Busan, Pusan-Kwangyokshi, Corea del Sur, 49241
- Pusan National University Hospital ( Site 0568)
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Taegu-Kwangyokshi
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Daegu, Taegu-Kwangyokshi, Corea del Sur, 41944
- Kyungpook National University Hospital ( Site 0569)
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Capital Region
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Herlev, Capital Region, Dinamarca, 2730
- Herlev Hospital ( Site 0170)
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Central Jutland
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Aarhus N, Central Jutland, Dinamarca, 8200
- Aarhus Universitets hospital ( Site 0175)
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Region Syddanmark
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Odense, Region Syddanmark, Dinamarca, 5000
- Odense Universitetshospital ( Site 0160)
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Madrid, España, 28007
- Hospital General Universitario Gregorio Maranon ( Site 0598)
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Madrid, España, 28034
- Hospital Ramon y Cajal ( Site 0593)
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Madrid, España, 28040
- Hospital Clinico San Carlos ( Site 0597)
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Seville, España, 41013
- Hospital Virgen del Rocio ( Site 0591)
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Madrid
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Majadahonda, Madrid, España, 28222
- Hospital Universitario Puerta de Hierro ( Site 0596)
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Valenciana, Comunitat
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Valencia, Valenciana, Comunitat, España, 46014
- Hospital General Universitario de Valencia ( Site 0595)
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Arizona
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Tucson, Arizona, Estados Unidos, 85711
- Arizona Oncology Associates PC- HOPE ( Site 0770)
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California
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La Jolla, California, Estados Unidos, 92037
- Scripps Clinic Torrey Pines ( Site 0714)
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Los Angeles, California, Estados Unidos, 90033
- USC Norris Comprehensive Cancer Center ( Site 0717)
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Los Angeles, California, Estados Unidos, 90404
- UCLA Hematology/Oncology - Santa Monica ( Site 0720)
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Orange, California, Estados Unidos, 92868
- UC Irvine Health ( Site 0718)
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06510
- Yale Cancer Center ( Site 0724)
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Florida
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Tampa, Florida, Estados Unidos, 33606
- Tampa General Hospital ( Site 0764)
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Idaho
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Boise, Idaho, Estados Unidos, 83712
- Mountain States Tumor Institute ( Site 0773)
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242
- University of Iowa Hospital and Clinics ( Site 0729)
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Kansas
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Westwood, Kansas, Estados Unidos, 66205
- University of Kansas Cancer Center ( Site 0731)
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40202
- University of Louisville ( Site 0757)
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70112
- Tulane Medical Center ( Site 0787)
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New Orleans, Louisiana, Estados Unidos, 70112
- University Medical Center New Orleans ( Site 0733)
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Michigan
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Detroit, Michigan, Estados Unidos, 48202
- Henry Ford Hospital-GI/Hepatology Research ( Site 0735)
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Missouri
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St Louis, Missouri, Estados Unidos, 63110
- Saint Louis University ( Site 0769)
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87106
- University of New Mexico Comprehensive Cancer Center ( Site 0805)
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New York
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Lake Success, New York, Estados Unidos, 11042
- Monter Cancer Center ( Site 0780)
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New York, New York, Estados Unidos, 10029
- Icahn School of Medicine at Mount Sinai ( Site 0744)
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North Carolina
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Winston-Salem, North Carolina, Estados Unidos, 27157
- Wake Forest Baptist Health ( Site 0741)
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45219
- University of Cincinnati Medical Center ( Site 0791)
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Columbus, Ohio, Estados Unidos, 43210
- The Ohio State University Wexner Medical Center ( Site 0759)
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Sylvania, Ohio, Estados Unidos, 43560
- ProMedica Flower Hospital ( Site 0796)
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73104
- Stephenson Cancer Center ( Site 0745)
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Oregon
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Portland, Oregon, Estados Unidos, 97239
- OHSU Center for Health & Healing ( Site 0746)
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Pennsylvania
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Hershey, Pennsylvania, Estados Unidos, 17033-0850
- Penn State Hershey Medical Center ( Site 0766)
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Texas
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Houston, Texas, Estados Unidos, 77030
- Houston Methodist Research Institute ( Site 0784)
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West Virginia
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Huntington, West Virginia, Estados Unidos, 25701
- Edwards Comprehensive Cancer Center ( Site 0786)
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Auvergne
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Lyon, Auvergne, Francia, 69004
- Hopital de la Croix-Rousse ( Site 0193)
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Bouches-du-Rhone
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Marseille, Bouches-du-Rhone, Francia, 13005
- Hopital de la Timone ( Site 0188)
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Gironde
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Pessac, Gironde, Francia, 33604
- CHU Bordeaux Haut-Leveque ( Site 0185)
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Meurthe-et-Moselle
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Vandœuvre-lès-Nancy, Meurthe-et-Moselle, Francia, 54500
- C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 0180)
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Val-de-Marne
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Créteil, Val-de-Marne, Francia, 94000
- A.P.H. Paris, Hopital Henri Mondor ( Site 0179)
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Villejuif, Val-de-Marne, Francia, 94800
- Hopital Paul Brousse ( Site 0182)
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Shatin, Hong Kong
- Prince of Wales Hospital ( Site 0242)
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Budapest, Hungría, 1085
- Semmelweis University ( Site 0264)
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Somogy County
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Kaposvár, Somogy County, Hungría, 7400
- Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 0267)
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Zala County
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Zalaegerszeg, Zala County, Hungría, 8900
- Zala Megyei Szent Rafael Korhaz ( Site 0265)
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Dublin, Irlanda, D04 T6F4
- St Vincents University Hospital ( Site 0690)
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Afula, Israel, 1834111
- Emek Medical Center ( Site 0307)
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Haifa, Israel, 3109601
- Rambam Health Care Campus-Oncology Division ( Site 0305)
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Jerusaelm, Israel, 9112001
- Hadassah Ein Karem Jerusalem ( Site 0303)
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Petah Tikva, Israel, 4941 492
- Rabin Medical Center ( Site 0304)
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Tel Aviv, Israel, 6423906
- Sourasky Medical Center ( Site 0306)
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Brescia, Italia, 25123
- Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 0334)
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Milan, Italia, 20122
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico ( Site 0325)
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Naples, Italia, 80131
- Az Osp di Rilievo Nazionale A. Cardarelli ( Site 0329)
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Ravenna, Italia, 48121
- Azienda USL della Romagna-Dipartimento di Oncologia ed Ematologia ( Site 0332)
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Roma, Italia, 00168
- Policlinico Universitario -Agostino Gemelli ( Site 0328)
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Campania
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Naples, Campania, Italia, 80147
- Ospedale del Mare ( Site 0327)
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Milano
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Milan, Milano, Italia, 20162
- ASST Grande Ospedale Metropolitano Niguarda-Oncologia Falck ( Site 0331)
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Piedmont
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Turin, Piedmont, Italia, 10128
- Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 0333)
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Sicily
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Messina, Sicily, Italia, 98124
- AOU Policlinico G. Martino ( Site 0324)
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Chiba, Japón, 260-8677
- Chiba University Hospital ( Site 0346)
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Fukuoka, Japón, 8108563
- National Hospital Organization Kyushu Medical Center ( Site 0361)
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Hiroshima, Japón, 734-8551
- Hiroshima University Hospital ( Site 0360)
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Kumamoto, Japón, 860-8556
- Kumamoto University Hospital ( Site 0372)
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Kyoto, Japón, 602-8566
- University Hospital,Kyoto Prefectural University of Medicine ( Site 0367)
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Osaka, Japón, 541-8567
- Osaka International Cancer Institute ( Site 0357)
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Osaka, Japón, 543-8555
- Japanese Red Cross Osaka Hospital ( Site 0356)
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Saga, Japón, 840-8571
- Saga-Ken Medical Centre Koseikan ( Site 0363)
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Tokyo, Japón, 105-8470
- Toranomon Hospital ( Site 0349)
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Tokyo, Japón, 113-0033
- Juntendo University Hospital ( Site 0371)
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Tokyo, Japón, 113-8655
- The University of Tokyo Hospital ( Site 0348)
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Chiba
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Kashiwa, Chiba, Japón, 277-8577
- National Cancer Center Hospital East ( Site 0347)
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Ehime
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Tōon, Ehime, Japón, 791-0295
- Ehime University Hospital ( Site 0368)
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Fukuoka
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Kurume, Fukuoka, Japón, 830-0011
- Kurume University Hospital ( Site 0362)
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Hokkaido
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Sapporo, Hokkaido, Japón, 060-0033
- Sapporo Kosei General Hospital ( Site 0345)
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Ishikawa-ken
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Kanazawa, Ishikawa-ken, Japón, 920-8641
- Kanazawa University Hospital ( Site 0354)
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Kagawa-ken
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Takamatsu, Kagawa-ken, Japón, 760-8557
- Kagawa Prefectural Central Hospital ( Site 0364)
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Kanagawa
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Kawasaki, Kanagawa, Japón, 213-8587
- Toranomon Hospital Kajigaya ( Site 0369)
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Yokohama, Kanagawa, Japón, 232-0024
- Yokohama City University Medical Center ( Site 0351)
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Yokohama, Kanagawa, Japón, 241-8515
- Kanagawa Cancer Center ( Site 0352)
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Nara
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Kashihara, Nara, Japón, 634-8522
- Nara Medical University Hospital ( Site 0359)
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Osaka
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Sayama, Osaka, Japón, 589-8511
- Kindai University Hospital ( Site 0358)
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Saitama
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Iruma-gun, Saitama, Japón, 350-0495
- Saitama Medical University Hospital ( Site 0370)
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Shizuoka
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Suntogun, Shizuoka, Japón, 411-8777
- Shizuoka Cancer Center ( Site 0365)
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Tochigi
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Shimotsuke, Tochigi, Japón, 329-0498
- Jichi Medical University Hospital ( Site 0353)
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Oslo, Noruega, 0450
- Oslo Universitetssykehus Ullevål ( Site 0500)
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Auckland, Nueva Zelanda, 1023
- Auckland City Hospital ( Site 0459)
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Utrecht, Países Bajos, 3584 CX
- Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 0441)
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Limburg
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Maastricht, Limburg, Países Bajos, 6229 HX
- Maastricht University Medical Centre ( Site 0440)
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North Holland
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Amsterdam, North Holland, Países Bajos, 1105 AZ
- AMC ( Site 0438)
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South Holland
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Leiden, South Holland, Países Bajos, 2333 ZA
- Leids Universitair Medisch Centrum-Medical Oncology ( Site 0442)
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Rotterdam, South Holland, Países Bajos, 3015 GD
- Erasmus University Medical Center ( Site 0439)
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Anhui
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Heifei, Anhui, Porcelana, 230001
- Anhui Provincial Hospital ( Site 0092)
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100142
- Beijing Cancer Hospital ( Site 0099)
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Beijing, Beijing Municipality, Porcelana, 100142
- Beijing Cancer Hospital ( Site 0105)
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Beijing, Beijing Municipality, Porcelana, 100730
- Peking Union Medical College Hospital ( Site 0087)
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Porcelana, 400042
- Chinese People s Liberation Army Army Characteristic Medical Center ( Site 0117)
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Chongqing, Chongqing Municipality, Porcelana, 404000
- Chongqing University Three Gorges Hospital ( Site 0859)
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Fujian
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Fuzhou, Fujian, Porcelana, 350014
- Fujian Provincial Cancer Hospital ( Site 0085)
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Fuzhou, Fujian, Porcelana, 350014
- The First Affiliated Hospital of Fujian Medical University ( Site 0089)
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Fuzhou, Fujian, Porcelana, 350008
- Mengchao Hepatobiliary Hospital of Fujian Medical University ( Site 0121)
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Xiamen, Fujian, Porcelana, 361015
- Zhongshan Hospital Fudan University (Xiamen Branch) ( Site 0133)
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510000
- Zhujiang Hospital of Southern Medical University ( Site 0115)
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Guangzhou, Guangdong, Porcelana, 510080
- Guangdong Provincial People s Hospital ( Site 0100)
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Guangzhou, Guangdong, Porcelana, 510515
- NANFANG HOSPITAL SOUTHERN MEDICAL UNIVERSITY ( Site 0088)
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Guangzhou, Guangdong, Porcelana, 510700
- SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 0128)
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Zhuhai, Guangdong, Porcelana, 519000
- Jinan University - Zhuhai People's Hospital-Intervention Department ( Site 0856)
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Guangxi
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Nanning, Guangxi, Porcelana, 530021
- Guangxi Medical University Affiliated Tumor Hospital-Hepatological surgery ( Site 0862)
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Hainan
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Haikou, Hainan, Porcelana, 570311
- Hainan General Hospital ( Site 0112)
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Heilongjiang
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Harbin, Heilongjiang, Porcelana, 150081
- Harbin Medical University Cancer Hospital ( Site 0090)
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Henan
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Zhengzhou, Henan, Porcelana, 450008
- Henan Cancer Hospital ( Site 0114)
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Hubei
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Wuhan, Hubei, Porcelana, 430079
- Hubei Cancer Hospital ( Site 0101)
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Wuhan, Hubei, Porcelana, 430000
- Tongji Hospital Tongji Medical,Science & Technology ( Site 0126)
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Hunan
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Changsha, Hunan, Porcelana, 410005
- Hunan Provincial People's Hospital ( Site 0113)
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Changsha, Hunan, Porcelana, 410013
- Hunan Cancer Hospital ( Site 0096)
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Jiangsu
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Suzhou, Jiangsu, Porcelana, 215006
- The First Affiliated Hospital of Soochow University ( Site 0120)
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Jiangxi
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Nanchang, Jiangxi, Porcelana, 330029
- Jiangxi Provincial Cancer Hospital-Cancer Hospital ( Site 0134)
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Shaanxi
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Xi'an, Shaanxi, Porcelana, 710100
- Xi'an International Medical Center Hospital ( Site 0860)
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200028
- The Third Affiliated Hospital of the PLA Navy Medical University ( Site 0123)
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Shanghai, Shanghai Municipality, Porcelana, 200032
- Fudan University Shanghai Cancer Center ( Site 0106)
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Shanghai, Shanghai Municipality, Porcelana, 200032
- Zhongshan Hospital Fudan University ( Site 0084)
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Shanxi
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Xi’an, Shanxi, Porcelana, 710048
- The First Affiliated Hospital of Xi an Jiaotong University ( Site 0108)
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Sichuan
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Chengdu, Sichuan, Porcelana, 610041
- West China Hospital of Sichuan University ( Site 0119)
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Suining, Sichuan, Porcelana, 629000
- Suining Central Hospital ( Site 0857)
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Porcelana, 300060
- Tianjin Medical University Cancer Institute & Hospital ( Site 0098)
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Tianjin, Tianjin Municipality, Porcelana, 300170
- Tianjin Third Central Hospital ( Site 0861)
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Yunnan
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Kunming, Yunnan, Porcelana, 650200
- The First Hospital of Kunming ( Site 0124)
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Zhejiang
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Hangzhou, Zhejiang, Porcelana, 310009
- 2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0110)
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Hangzhou, Zhejiang, Porcelana, 310018
- Sir Run Run Shaw Hospital ( Site 0094)
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Hangzhou, Zhejiang, Porcelana, 310022
- Zhejiang Cancer Hospital ( Site 0103)
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Ningbo, Zhejiang, Porcelana, 315048
- Ningbo Medical Center LiHuili Hospital ( Site 0132)
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-
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Coimbra, Portugal, 3000-075
- Centro Hospitalar e Universitario de Coimbra ( Site 0502)
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Lisbon, Portugal, 1169-050
- Unidade Local de Saude de São José - Hospital de Santo Antonio dos Capuchos ( Site 0505)
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Porto, Portugal, 4099-001
- Centro Hospitalar do Porto, E.P.E. - Hospital Geral de Sto. Antonio ( Site 0504)
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Porto, Portugal, 4200-072
- Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0503)
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Porto, Portugal, 4200-319
- Centro Hospitalar de Sao Joao. EPE - Hospital de Sao Joao ( Site 0501)
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-
-
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Hato Rey, Puerto Rico, 00917
- Puerto Rico Medical Research Center LLC ( Site 0523)
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Ponce, Puerto Rico, 00717
- Ad-Vance Medical Research LLC ( Site 0527)
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San Juan, Puerto Rico, 00921-3201
- VA Caribbean Healthcare System ( Site 0524)
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San Juan, Puerto Rico, 00927
- FDI Clinical Research ( Site 0522)
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-
-
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London, City of
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London, London, City of, Reino Unido, EC1A 7BE
- Barts Health NHS Trust ( Site 0692)
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London, London, City of, Reino Unido, SW3 6JJ
- Royal Marsden NHS Foundation Trust ( Site 0694)
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Sutton, London, City of, Reino Unido, SM2 5PT
- Royal Marsden NHS Trust ( Site 0693)
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Bangkok
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Bangkok, Bangkok, Tailandia, 10330
- Chulalongkorn University ( Site 0627)
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Bangkok, Bangkok, Tailandia, 10400
- Ramathibodi Hospital, Mahidol University ( Site 0628)
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Bangkok, Bangkok, Tailandia, 10700
- Faculty of Medicine Siriraj Hospital ( Site 0629)
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Kaohsiung City, Taiwán, 807
- Kaohsiung Medical University Hospital ( Site 0611)
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Taichung, Taiwán, 40447
- China Medical University Hospital-Surgical Department ( Site 0610)
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Taichung, Taiwán, 407
- Taichung Veterans General Hospital ( Site 0613)
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Tainan, Taiwán, 70457
- National Cheng Kung University Hospital ( Site 0608)
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Taipei, Taiwán, 10002
- National Taiwan University Hospital ( Site 0606)
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Taipei, Taiwán, 112201
- Taipei Veterans General Hospital-Division of Gastroenterology & Hepatology, Department of Medicine ( Site 0612)
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Taoyuan, Taiwán, 333
- Chang Gung Medical Foundation. Linkou ( Site 0607)
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Kaohsiung
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Kaohsiung City, Kaohsiung, Taiwán, 833
- Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0609)
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Ankara, Turquía (Türkiye), 06230
- Hacettepe University Medical Faculty ( Site 0653)
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Ankara, Turquía (Türkiye), 06800
- Ankara City Hospital-Medical Oncology ( Site 0661)
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Edirne, Turquía (Türkiye), 22030
- Trakya University Medical Faculty Balkan Oncology Hospital ( Site 0648)
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Istanbul, Turquía (Türkiye), 34093
- Bezmialem Vakf Üniversitesi-Oncology ( Site 0660)
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Izmir, Turquía (Türkiye), 35100
- Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 0654)
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Izmir, Turquía (Türkiye), 35575
- I.E.U. Medical Point Hastanesi ( Site 0649)
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Konya, Turquía (Türkiye), 42080
- Konya Necmettin Erbakan University Medical Faculty ( Site 0652)
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Malatya, Turquía (Türkiye), 44280
- Inonu Universitesi Medical Fakultesi ( Site 0650)
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Kharkiv Oblast
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Kharkiv, Kharkiv Oblast, Ucrania, 61070
- Communal non profit enterprise Regional Clinical Oncology Center ( Site 0669)
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Descripción
Criterios de inclusión:
- Tiene un diagnóstico de HCC confirmado por radiología, histología o citología.
- Tiene HCC localizado en el hígado y no es susceptible de tratamiento curativo
- Los participantes con el virus de la hepatitis C (HCV) son elegibles si el tratamiento se completó al menos 1 mes antes de comenzar la intervención del estudio.
- Los participantes con el virus de la hepatitis B (VHB) son elegibles
- Tiene la presión arterial adecuadamente controlada con o sin medicamentos antihipertensivos
- Tiene una función adecuada del órgano.
Criterio de exclusión:
- Actualmente es candidato a trasplante hepático.
- Ha tenido sangrado gástrico en los últimos 6 meses
- Tiene ascitis que no se controla con medicamentos.
- Tiene un deterioro cardiovascular significativo dentro de los 12 meses posteriores a la primera dosis de la intervención del estudio, como insuficiencia cardíaca congestiva
- Tiene una herida, úlcera o fractura ósea grave que no cicatriza
- Ha recibido terapia locorregional para lesiones hepáticas existentes
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Lenvatinib más pembrolizumab más TACE
Los participantes recibirán una combinación de lenvatinib, pembrolizumab y TACE.
Lenvatinib se administrará a una dosis de 12 mg (para participantes con peso corporal de detección ≥60 kg) u 8 mg (para participantes con peso corporal de detección
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Administrado a una dosis de 12 mg (para participantes con peso corporal de detección ≥60 kg) u 8 mg (para participantes con peso corporal de detección
Otros nombres:
Administrado por infusión IV a una dosis de 400 mg una vez cada 6 semanas (Q6W).
Otros nombres:
Realizado como un procedimiento de fondo de agente(s) quimioterapéutico(s) y embólico(s).
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Comparador activo: Placebo oral más placebo IV más TACE
Los participantes recibirán una combinación de placebo oral equivalente a lenvatinib, placebo intravenoso equivalente a pembrolizumab y TACE.
El placebo oral equivalente a lenvatinib se administrará una vez al día durante cada ciclo de 21 días durante un máximo de 2 años (~35 ciclos) o más con la aprobación del patrocinador y el placebo IV equivalente a pembrolizumab se administrará una vez cada 6 semanas (Q6W) durante un máximo de a 2 años (~17 dosis).
Los participantes se someterán a TACE como procedimiento de fondo de agente(s) quimioterapéutico(s) y embólico(s).
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Realizado como un procedimiento de fondo de agente(s) quimioterapéutico(s) y embólico(s).
Placebo equivalente a lenvatinib administrado a través de cápsulas orales una vez al día durante cada ciclo de 21 días.
Placebo equivalente a pembrolizumab administrado mediante infusión IV una vez cada 6 semanas (Q6W).
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Periodo de tiempo: Up to approximately 43.5 Months
|
PFS was defined as the time from the first dose of study intervention to the first documented progressive disease (PD) per RECIST 1.1 by BICR or death due to any cause, whichever occurs first.
Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions.
In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
The appearance of one or more new lesions was also considered PD.
PFS per RECIST 1.1 as assessed by BICR was reported.
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Up to approximately 43.5 Months
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Overall Survival (OS)
Periodo de tiempo: Up to approximately 61.7 Months
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OS was defined as the time from randomization to death due to any cause.
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Up to approximately 61.7 Months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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PFS Per Modified RECIST (mRECIST) as Assessed by BICR
Periodo de tiempo: Up to approximately 61.7 Months
|
PFS was defined as the time from the first dose of study intervention to the first documented PD per mRECIST by BICR or death due to any cause, whichever occurs first.
mRECIST for hepatocellular carcinoma (HCC) allows evaluation of treatment effects that are not reflected in simple total size changes of lesions.
Per mRECIST, PD was defined as an increase of at least 20% in the SODs of viable target lesions, taking as reference the smallest SODs of viable target lesions recorded since the treatment started.
PFS per mRECIST as assessed by BICR was reported.
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Up to approximately 61.7 Months
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Objective Response Rate (ORR) Per mRECIST as Assessed by BICR
Periodo de tiempo: Up to approximately 61.7 Months
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ORR was defined as the percentage of participants who achieve a confirmed complete response (CR) (disappearance of any intratumoral arterial enhancement in all target lesions) or a partial response (PR) (at least a 30% decrease in the SOD of viable [contrast enhancement in the arterial phase] target lesions, taking as reference the baseline SOD of target lesions) per mRECIST as assessed by BICR.
mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions.
The percentage of participants who experienced CR or PR per mRECIST as assessed BICR was presented.
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Up to approximately 61.7 Months
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Disease Control Rate (DCR) Per mRECIST as Assessed by BICR
Periodo de tiempo: Up to approximately 61.7 Months
|
DCR was defined as the percentage of participants who have achieved a confirmed complete response (CR) (disappearance of any intratumoral arterial enhancement in all target lesions) or a partial response (PR) (at least a 30% decrease in the SOD of viable [contrast enhancement in the arterial phase] target lesions, taking as reference the baseline SOD of target lesions) per mRECIST as assessed by BICR.
mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions.
PD was defined as at least a 20% increase in the SOD of target lesions.
In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
The appearance of one or more new lesions was also considered PD.
The percentage of participants who achieved CR, PR, or SD after ≥6 weeks per mRECIST assessed by BICR was presented.
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Up to approximately 61.7 Months
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Duration of Response (DOR) Per mRECIST as Assessed by BICR
Periodo de tiempo: Up to approximately 61.7 Months
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For participants who demonstrated confirmed CR or PR per mRECIST assessed by BICR, DOR was defined as the time from the first documented evidence of a confirmed complete response (CR) (disappearance of any intratumoral arterial enhancement in all target lesions) or a partial response (PR) (at least a 30% decrease in the SOD of viable [contrast enhancement in the arterial phase] target lesions, taking as reference the baseline SOD of target lesions) per mRECIST as assessed by BICR.
mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions.
PD was defined as at least a 20% increase in the SOD of target lesions.
In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
The appearance of one or more new lesions was also considered PD.
The DOR as assessed using mRECIST for all participants who experienced a confirmed CR or PR was presented.
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Up to approximately 61.7 Months
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Time-To-Progression (TTP) Per mRECIST as Assessed by BICR
Periodo de tiempo: Up to approximately 61.7 Months
|
TTP was defined as the time from the first dose of study intervention to the first documented PD per mRECIST assessed by BICR.
mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions.
PD was defined as at least a 20% increase in the SOD of target lesions.
In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
The appearance of one or more new lesions was also considered PD.
TTP per mRECIST as assessed by BICR was presented.
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Up to approximately 61.7 Months
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Number of Participants Who Experienced At Least One Adverse Event (AE)
Periodo de tiempo: Up to approximately 71.1 Months
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An AE will be any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
The number of participants who experienced an AE will be reported.
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Up to approximately 71.1 Months
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Percentage of Participants Who Experience At Least One Serious Adverse Event (SAE)
Periodo de tiempo: Up to approximately 71.1 Months
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An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was another important medical event.
The number of participants with an SAE was reported.
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Up to approximately 71.1 Months
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Number of Participants Who Experience At Least One Hepatic Event of Clinical Interest (ECI)
Periodo de tiempo: Up to approximately 71.1 Months
|
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Hepatic events of clinical interest (ECIs) included any of the following events if the event was considered not due to disease progression as judged by the investigator: among participants with Baseline ALT <2 × ULN: ALT ≥5 × ULN; among participants with Baseline ALT ≥2 × ULN: ALT >3 × the Baseline level; ALT >500 U/L regardless of baseline level; total bilirubin >3.0 mg/dL; hepatic decompensation diagnosed clinically (regardless of laboratory values) including new onset clinically detectable ascites requiring intervention for >3 days, hepatic encephalopathy, or gastrointestinal bleeding suggestive of portal hypertension.
The number of participants with a hepatic AE of clinical interest was reported.
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Up to approximately 71.1 Months
|
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Number of Participants Who Discontinue Study Treatment Due to an AE
Periodo de tiempo: Up to approximately 71.1 Months
|
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
The number of participants that discontinued study treatment due to an AE was reported.
|
Up to approximately 71.1 Months
|
|
ORR Per RECIST 1.1 as Assessed by BICR
Periodo de tiempo: Up to approximately 61.7 Months
|
ORR was defined as the percentage of participants who achieve a confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters [SOD] of target lesions) per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions in total and 5 per organ, and assessed by BICR.
The percentage of participants who experienced CR or PR per RECIST 1.1 as assessed BICR was presented.
|
Up to approximately 61.7 Months
|
|
DCR Per RECIST 1.1 as Assessed by BICR
Periodo de tiempo: Up to approximately 61.7 Months
|
DCR was defined as the percentage of participants who have achieved CR (disappearance of all target lesions), PR (at least a 30% decrease in the SOD of target lesions), or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD) after ≥6 weeks (the start of the window for the first scheduled scan) per RECIST 1.1 assessed by BICR.
Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD was defined as at least a 20% increase in the SOD of target lesions.
In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
The appearance of one or more new lesions was also considered PD.
The percentage of participants who achieved CR, PR, or SD after ≥6 weeks per RECIST 1.1 assessed by BICR was presented.
|
Up to approximately 61.7 Months
|
|
DOR Per RECIST 1.1 as Assessed by BICR
Periodo de tiempo: Up to approximately 61.7 Months
|
For participants who demonstrated confirmed CR or PR per RECIST 1.1 assessed by BICR, DOR was defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the SOD of target lesions) until progressive disease (PD) or death due to any cause, whichever occurred first.
Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD was defined as at least a 20% increase in the SOD of target lesions.
In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
The appearance of one or more new lesions was also considered PD.
The DOR as assessed using RECIST 1.1 for all participants who experienced a confirmed CR or PR was presented.
|
Up to approximately 61.7 Months
|
|
TTP Per RECIST 1.1 as Assessed by BICR
Periodo de tiempo: Up to approximately 61.7 Months
|
TTP was defined as the time from the first dose of study intervention to the first documented PD per RECIST 1.1 assessed by BICR.
Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD was defined as at least a 20% increase in the SOD of target lesions.
In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
The appearance of one or more new lesions was also considered PD.
TTP per RECIST 1.1 as assessed by BICR was presented.
|
Up to approximately 61.7 Months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Medical Director, Merck Sharp & Dohme LLC
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Verset G, Borbath I, Karwal M, Verslype C, Van Vlierberghe H, Kardosh A, Zagonel V, Stal P, Sarker D, Palmer DH, Vogel A, Edeline J, Cattan S, Kudo M, Cheng AL, Ogasawara S, Daniele B, Chan SL, Knox JJ, Qin S, Siegel AB, Chisamore M, Hatogai K, Wang A, Finn RS, Zhu AX. Pembrolizumab Monotherapy for Previously Untreated Advanced Hepatocellular Carcinoma: Data from the Open-Label, Phase II KEYNOTE-224 Trial. Clin Cancer Res. 2022 Jun 13;28(12):2547-2554. doi: 10.1158/1078-0432.CCR-21-3807.
- Taylor MH, Schmidt EV, Dutcus C, Pinheiro EM, Funahashi Y, Lubiniecki G, Rasco D. The LEAP program: lenvatinib plus pembrolizumab for the treatment of advanced solid tumors. Future Oncol. 2021 Feb;17(6):637-648. doi: 10.2217/fon-2020-0937. Epub 2020 Dec 10.
- Kloeckner R, Galle PR, Bruix J. Local and Regional Therapies for Hepatocellular Carcinoma. Hepatology. 2021 Jan;73 Suppl 1:137-149. doi: 10.1002/hep.31424. Epub 2020 Nov 6. No abstract available.
- Llovet JM, Vogel A, Madoff DC, Finn RS, Ogasawara S, Ren Z, Mody K, Li JJ, Siegel AB, Dubrovsky L, Kudo M. Randomized Phase 3 LEAP-012 Study: Transarterial Chemoembolization With or Without Lenvatinib Plus Pembrolizumab for Intermediate-Stage Hepatocellular Carcinoma Not Amenable to Curative Treatment. Cardiovasc Intervent Radiol. 2022 Apr;45(4):405-412. doi: 10.1007/s00270-021-03031-9. Epub 2022 Feb 4.
- Kudo M, Ren Z, Guo Y, Han G, Lin H, Zheng J, Ogasawara S, Kim JH, Zhao H, Li C, Madoff DC, Ghobrial RM, Kawaoka T, Gerolami R, Ikeda M, Kumada H, El-Khoueiry AB, Vogel A, Peng X, Mody K, Dutcus C, Dubrovsky L, Siegel AB, Finn RS, Llovet JM; LEAP-012 investigators. Transarterial chemoembolisation combined with lenvatinib plus pembrolizumab versus dual placebo for unresectable, non-metastatic hepatocellular carcinoma (LEAP-012): a multicentre, randomised, double-blind, phase 3 study. Lancet. 2025 Jan 18;405(10474):203-215. doi: 10.1016/S0140-6736(24)02575-3. Epub 2025 Jan 8.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
22 de mayo de 2020
Finalización primaria (Actual)
19 de agosto de 2025
Finalización del estudio (Actual)
26 de marzo de 2026
Fechas de registro del estudio
Enviado por primera vez
27 de enero de 2020
Primero enviado que cumplió con los criterios de control de calidad
27 de enero de 2020
Publicado por primera vez (Actual)
29 de enero de 2020
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
1 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Neoplasias por tipo histológico
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Enfermedades del HIGADO
- Neoplasias Glandulares y Epiteliales
- Adenocarcinoma
- Neoplasias Hepaticas
- Carcinoma
- Carcinoma Hepatocelular
- Enfermedad de Parkinson 4, cuerpo autosómico dominante de Lewy
- Agentes antineoplásicos inmunológicos
- Inhibidores de puntos de control inmunitarios
- Agentes antineoplásicos
- Mecanismos moleculares de acción farmacológica.
- Inhibidores de enzimas
- Inhibidores de la proteína quinasa
- pembrolizumab
- lenvatinib
Otros números de identificación del estudio
- 7902-012
- 2019 (Subvención/contrato del NIH de EE. UU.: Chief Medical Office (CMO) Alberta Health Services)
- MK-7902-012 (Otro identificador: MSD Protocol Number)
- LEAP-012 (Otro identificador: MSD)
- E7080-G000-318 (Otro identificador: Eisai Protocol Number)
- 205286 (Identificador de registro: JAPIC-CTI)
- 2019-002345-37 (Número EudraCT)
- 2022-502116-36-00 (Identificador de registro: EU CT)
- U1111-1283-3439 (Identificador de registro: UTN)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .