난치성/비전이성 간세포 암종(MK-7902-012/E7080-G000-318/E7080-G000-318/E7080-G000-318/ 도약-012)
2026년 9월 1일 업데이트: Merck Sharp & Dohme LLC
렌바티닙(E7080/MK-7902)과 펨브롤리주맙(MK-3475)을 경동맥 화학색전술(TACE) 대 TACE 병용의 안전성 및 효능을 평가하기 위한 제3상 다기관, 무작위, 이중맹검, 활성 대조 임상 연구 불치/비전이성 간세포 암종(LEAP-012)이 있는 참가자
이 연구의 목적은 난치성 비전이성 간세포 암종(HCC) 참가자를 대상으로 렌바티닙 및 펨브롤리주맙과 TACE 병용 요법과 TACE 플러스 경구 및 정맥(IV) 위약의 효능 및 안전성을 평가하는 것입니다.
1차 가설은 TACE와 병용한 펨브롤리주맙 + 렌바티닙이 무진행 생존(PFS) 및 전체 생존(OS) 측면에서 위약 + TACE보다 우수하다는 것입니다.
연구 개요
연구 유형
중재적
등록 (실제)
480
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Utrecht, 네덜란드, 3584 CX
- Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 0441)
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Limburg
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Maastricht, Limburg, 네덜란드, 6229 HX
- Maastricht University Medical Centre ( Site 0440)
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North Holland
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Amsterdam, North Holland, 네덜란드, 1105 AZ
- AMC ( Site 0438)
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South Holland
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Leiden, South Holland, 네덜란드, 2333 ZA
- Leids Universitair Medisch Centrum-Medical Oncology ( Site 0442)
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Rotterdam, South Holland, 네덜란드, 3015 GD
- Erasmus University Medical Center ( Site 0439)
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Oslo, 노르웨이, 0450
- Oslo Universitetssykehus Ullevål ( Site 0500)
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Auckland, 뉴질랜드, 1023
- Auckland City Hospital ( Site 0459)
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Kaohsiung City, 대만, 807
- Kaohsiung Medical University Hospital ( Site 0611)
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Taichung, 대만, 40447
- China Medical University Hospital-Surgical Department ( Site 0610)
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Taichung, 대만, 407
- Taichung Veterans General Hospital ( Site 0613)
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Tainan, 대만, 70457
- National Cheng Kung University Hospital ( Site 0608)
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Taipei, 대만, 10002
- National Taiwan University Hospital ( Site 0606)
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Taipei, 대만, 112201
- Taipei Veterans General Hospital-Division of Gastroenterology & Hepatology, Department of Medicine ( Site 0612)
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Taoyuan, 대만, 333
- Chang Gung Medical Foundation. Linkou ( Site 0607)
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Kaohsiung
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Kaohsiung City, Kaohsiung, 대만, 833
- Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0609)
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Seoul, 대한민국, 03080
- Seoul National University Hospital ( Site 0567)
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Seoul, 대한민국, 03722
- Severance Hospital Yonsei University Health System ( Site 0564)
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Seoul, 대한민국, 05505
- Asan Medical Center ( Site 0565)
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Seoul, 대한민국, 06351
- Samsung Medical Center ( Site 0566)
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Seoul, 대한민국, 06591
- The Catholic University of Korea St. Mary s Hospital ( Site 0571)
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Seoul, 대한민국, 08308
- Korea University Guro Hospital ( Site 0573)
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Jeonranamdo
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Hwasun, Jeonranamdo, 대한민국, 58128
- Chonnam National University Hwasun Hospital ( Site 0572)
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Kyonggi-do
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Seongnam-si, Kyonggi-do, 대한민국, 13620
- Seoul National University Bundang Hospital ( Site 0570)
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Pusan-Kwangyokshi
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Busan, Pusan-Kwangyokshi, 대한민국, 49241
- Pusan National University Hospital ( Site 0568)
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Taegu-Kwangyokshi
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Daegu, Taegu-Kwangyokshi, 대한민국, 41944
- Kyungpook National University Hospital ( Site 0569)
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Capital Region
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Herlev, Capital Region, 덴마크, 2730
- Herlev Hospital ( Site 0170)
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Central Jutland
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Aarhus N, Central Jutland, 덴마크, 8200
- Aarhus Universitets hospital ( Site 0175)
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Region Syddanmark
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Odense, Region Syddanmark, 덴마크, 5000
- Odense Universitetshospital ( Site 0160)
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Berlin, 독일, 13353
- Charite - Universitaetsmedizin ( Site 0204)
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Hamburg, 독일, 20246
- Universitaetsklinikum Hamburg-Eppendorf ( Site 0207)
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Baden-Wurttemberg
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Freiburg im Breisgau, Baden-Wurttemberg, 독일, 79106
- Universitaetsklinikum Freiburg ( Site 0199)
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Hesse
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Frankfurt am Main, Hesse, 독일, 60488
- Krankenhaus Nord-West GmbH ( Site 0208)
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Lower Saxony
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Hanover, Lower Saxony, 독일, 30625
- Medizinische Hochschule Hannover ( Site 0200)
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North Rhine-Westphalia
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Bonn, North Rhine-Westphalia, 독일, 53127
- Universitaetsklinikum Bonn ( Site 0203)
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Saxony
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Leipzig, Saxony, 독일, 04103
- Universitaetsklinikum Leipzig ( Site 0202)
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Saxony-Anhalt
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Halle, Saxony-Anhalt, 독일, 06120
- Universitaetsklinikum Halle ( Site 0213)
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Schleswig-Holstein
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Lübeck, Schleswig-Holstein, 독일, 23538
- Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0215)
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Arizona
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Tucson, Arizona, 미국, 85711
- Arizona Oncology Associates PC- HOPE ( Site 0770)
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California
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La Jolla, California, 미국, 92037
- Scripps Clinic Torrey Pines ( Site 0714)
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Los Angeles, California, 미국, 90033
- USC Norris Comprehensive Cancer Center ( Site 0717)
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Los Angeles, California, 미국, 90404
- UCLA Hematology/Oncology - Santa Monica ( Site 0720)
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Orange, California, 미국, 92868
- UC Irvine Health ( Site 0718)
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Connecticut
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New Haven, Connecticut, 미국, 06510
- Yale Cancer Center ( Site 0724)
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Florida
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Tampa, Florida, 미국, 33606
- Tampa General Hospital ( Site 0764)
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Idaho
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Boise, Idaho, 미국, 83712
- Mountain States Tumor Institute ( Site 0773)
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Iowa
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Iowa City, Iowa, 미국, 52242
- University of Iowa Hospital and Clinics ( Site 0729)
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Kansas
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Westwood, Kansas, 미국, 66205
- University of Kansas Cancer Center ( Site 0731)
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Kentucky
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Louisville, Kentucky, 미국, 40202
- University of Louisville ( Site 0757)
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Louisiana
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New Orleans, Louisiana, 미국, 70112
- Tulane Medical Center ( Site 0787)
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New Orleans, Louisiana, 미국, 70112
- University Medical Center New Orleans ( Site 0733)
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Michigan
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Detroit, Michigan, 미국, 48202
- Henry Ford Hospital-GI/Hepatology Research ( Site 0735)
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Missouri
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St Louis, Missouri, 미국, 63110
- Saint Louis University ( Site 0769)
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New Mexico
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Albuquerque, New Mexico, 미국, 87106
- University of New Mexico Comprehensive Cancer Center ( Site 0805)
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New York
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Lake Success, New York, 미국, 11042
- Monter Cancer Center ( Site 0780)
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New York, New York, 미국, 10029
- Icahn School of Medicine at Mount Sinai ( Site 0744)
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North Carolina
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Winston-Salem, North Carolina, 미국, 27157
- Wake Forest Baptist Health ( Site 0741)
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Ohio
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Cincinnati, Ohio, 미국, 45219
- University of Cincinnati Medical Center ( Site 0791)
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Columbus, Ohio, 미국, 43210
- The Ohio State University Wexner Medical Center ( Site 0759)
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Sylvania, Ohio, 미국, 43560
- ProMedica Flower Hospital ( Site 0796)
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73104
- Stephenson Cancer Center ( Site 0745)
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Oregon
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Portland, Oregon, 미국, 97239
- OHSU Center for Health & Healing ( Site 0746)
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Pennsylvania
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Hershey, Pennsylvania, 미국, 17033-0850
- Penn State Hershey Medical Center ( Site 0766)
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Texas
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Houston, Texas, 미국, 77030
- Houston Methodist Research Institute ( Site 0784)
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West Virginia
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Huntington, West Virginia, 미국, 25701
- Edwards Comprehensive Cancer Center ( Site 0786)
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São Paulo, 브라질, 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, 브라질, 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, 브라질, 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, 브라질, 89010-340
- Clinica de Oncologia Reichow ( Site 0052)
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São Paulo
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Barretos, São Paulo, 브라질, 14784-400
- Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 0058)
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Jaú, São Paulo, 브라질, 17210-120
- Fundacao Dr Amaral Carvalho ( Site 0050)
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São José do Rio Preto, São Paulo, 브라질, 15090-000
- Hospital de Base de Sao Jose de Rio Preto ( Site 0043)
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São Paulo, São Paulo, 브라질, 01323-001
- BP - A Beneficencia Portuguesa de São Paulo ( Site 0046)
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Madrid, 스페인, 28007
- Hospital General Universitario Gregorio Maranon ( Site 0598)
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Madrid, 스페인, 28034
- Hospital Ramon y Cajal ( Site 0593)
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Madrid, 스페인, 28040
- Hospital Clinico San Carlos ( Site 0597)
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Seville, 스페인, 41013
- Hospital Virgen del Rocio ( Site 0591)
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Madrid
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Majadahonda, Madrid, 스페인, 28222
- Hospital Universitario Puerta de Hierro ( Site 0596)
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Valenciana, Comunitat
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Valencia, Valenciana, Comunitat, 스페인, 46014
- Hospital General Universitario de Valencia ( Site 0595)
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Dublin, 아일랜드, D04 T6F4
- St Vincents University Hospital ( Site 0690)
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London, City of
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London, London, City of, 영국, EC1A 7BE
- Barts Health NHS Trust ( Site 0692)
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London, London, City of, 영국, SW3 6JJ
- Royal Marsden NHS Foundation Trust ( Site 0694)
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Sutton, London, City of, 영국, SM2 5PT
- Royal Marsden NHS Trust ( Site 0693)
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Kharkiv Oblast
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Kharkiv, Kharkiv Oblast, 우크라이나, 61070
- Communal non profit enterprise Regional Clinical Oncology Center ( Site 0669)
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Afula, 이스라엘, 1834111
- Emek Medical Center ( Site 0307)
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Haifa, 이스라엘, 3109601
- Rambam Health Care Campus-Oncology Division ( Site 0305)
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Jerusaelm, 이스라엘, 9112001
- Hadassah Ein Karem Jerusalem ( Site 0303)
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Petah Tikva, 이스라엘, 4941 492
- Rabin Medical Center ( Site 0304)
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Tel Aviv, 이스라엘, 6423906
- Sourasky Medical Center ( Site 0306)
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Brescia, 이탈리아, 25123
- Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 0334)
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Milan, 이탈리아, 20122
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico ( Site 0325)
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Naples, 이탈리아, 80131
- Az Osp di Rilievo Nazionale A. Cardarelli ( Site 0329)
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Ravenna, 이탈리아, 48121
- Azienda USL della Romagna-Dipartimento di Oncologia ed Ematologia ( Site 0332)
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Roma, 이탈리아, 00168
- Policlinico Universitario -Agostino Gemelli ( Site 0328)
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Campania
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Naples, Campania, 이탈리아, 80147
- Ospedale del Mare ( Site 0327)
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Milano
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Milan, Milano, 이탈리아, 20162
- ASST Grande Ospedale Metropolitano Niguarda-Oncologia Falck ( Site 0331)
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Piedmont
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Turin, Piedmont, 이탈리아, 10128
- Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 0333)
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Sicily
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Messina, Sicily, 이탈리아, 98124
- AOU Policlinico G. Martino ( Site 0324)
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Chiba, 일본, 260-8677
- Chiba University Hospital ( Site 0346)
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Fukuoka, 일본, 8108563
- National Hospital Organization Kyushu Medical Center ( Site 0361)
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Hiroshima, 일본, 734-8551
- Hiroshima University Hospital ( Site 0360)
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Kumamoto, 일본, 860-8556
- Kumamoto University Hospital ( Site 0372)
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Kyoto, 일본, 602-8566
- University Hospital,Kyoto Prefectural University of Medicine ( Site 0367)
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Osaka, 일본, 541-8567
- Osaka International Cancer Institute ( Site 0357)
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Osaka, 일본, 543-8555
- Japanese Red Cross Osaka Hospital ( Site 0356)
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Saga, 일본, 840-8571
- Saga-Ken Medical Centre Koseikan ( Site 0363)
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Tokyo, 일본, 105-8470
- Toranomon Hospital ( Site 0349)
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Tokyo, 일본, 113-0033
- Juntendo University Hospital ( Site 0371)
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Tokyo, 일본, 113-8655
- The University of Tokyo Hospital ( Site 0348)
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Chiba
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Kashiwa, Chiba, 일본, 277-8577
- National Cancer Center Hospital East ( Site 0347)
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Ehime
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Tōon, Ehime, 일본, 791-0295
- Ehime University Hospital ( Site 0368)
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Fukuoka
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Kurume, Fukuoka, 일본, 830-0011
- Kurume University Hospital ( Site 0362)
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Hokkaido
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Sapporo, Hokkaido, 일본, 060-0033
- Sapporo Kosei General Hospital ( Site 0345)
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Ishikawa-ken
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Kanazawa, Ishikawa-ken, 일본, 920-8641
- Kanazawa University Hospital ( Site 0354)
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Kagawa-ken
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Takamatsu, Kagawa-ken, 일본, 760-8557
- Kagawa Prefectural Central Hospital ( Site 0364)
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Kanagawa
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Kawasaki, Kanagawa, 일본, 213-8587
- Toranomon Hospital Kajigaya ( Site 0369)
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Yokohama, Kanagawa, 일본, 232-0024
- Yokohama City University Medical Center ( Site 0351)
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Yokohama, Kanagawa, 일본, 241-8515
- Kanagawa Cancer Center ( Site 0352)
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Nara
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Kashihara, Nara, 일본, 634-8522
- Nara Medical University Hospital ( Site 0359)
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Osaka
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Sayama, Osaka, 일본, 589-8511
- Kindai University Hospital ( Site 0358)
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Saitama
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Iruma-gun, Saitama, 일본, 350-0495
- Saitama Medical University Hospital ( Site 0370)
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Shizuoka
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Suntogun, Shizuoka, 일본, 411-8777
- Shizuoka Cancer Center ( Site 0365)
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Tochigi
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Shimotsuke, Tochigi, 일본, 329-0498
- Jichi Medical University Hospital ( Site 0353)
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Anhui
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Heifei, Anhui, 중국, 230001
- Anhui Provincial Hospital ( Site 0092)
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Beijing Municipality
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Beijing, Beijing Municipality, 중국, 100142
- Beijing Cancer Hospital ( Site 0099)
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Beijing, Beijing Municipality, 중국, 100142
- Beijing Cancer Hospital ( Site 0105)
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Beijing, Beijing Municipality, 중국, 100730
- Peking Union Medical College Hospital ( Site 0087)
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Chongqing Municipality
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Chongqing, Chongqing Municipality, 중국, 400042
- Chinese People s Liberation Army Army Characteristic Medical Center ( Site 0117)
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Chongqing, Chongqing Municipality, 중국, 404000
- Chongqing University Three Gorges Hospital ( Site 0859)
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Fujian
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Fuzhou, Fujian, 중국, 350014
- Fujian Provincial Cancer Hospital ( Site 0085)
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Fuzhou, Fujian, 중국, 350014
- The First Affiliated Hospital of Fujian Medical University ( Site 0089)
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Fuzhou, Fujian, 중국, 350008
- Mengchao Hepatobiliary Hospital of Fujian Medical University ( Site 0121)
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Xiamen, Fujian, 중국, 361015
- Zhongshan Hospital Fudan University (Xiamen Branch) ( Site 0133)
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Guangdong
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Guangzhou, Guangdong, 중국, 510000
- Zhujiang Hospital of Southern Medical University ( Site 0115)
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Guangzhou, Guangdong, 중국, 510080
- Guangdong Provincial People s Hospital ( Site 0100)
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Guangzhou, Guangdong, 중국, 510515
- NANFANG HOSPITAL SOUTHERN MEDICAL UNIVERSITY ( Site 0088)
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Guangzhou, Guangdong, 중국, 510700
- SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 0128)
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Zhuhai, Guangdong, 중국, 519000
- Jinan University - Zhuhai People's Hospital-Intervention Department ( Site 0856)
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Guangxi
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Nanning, Guangxi, 중국, 530021
- Guangxi Medical University Affiliated Tumor Hospital-Hepatological surgery ( Site 0862)
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Hainan
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Haikou, Hainan, 중국, 570311
- Hainan General Hospital ( Site 0112)
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Heilongjiang
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Harbin, Heilongjiang, 중국, 150081
- Harbin Medical University Cancer Hospital ( Site 0090)
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Henan
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Zhengzhou, Henan, 중국, 450008
- Henan Cancer Hospital ( Site 0114)
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Hubei
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Wuhan, Hubei, 중국, 430079
- Hubei Cancer Hospital ( Site 0101)
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Wuhan, Hubei, 중국, 430000
- Tongji Hospital Tongji Medical,Science & Technology ( Site 0126)
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Hunan
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Changsha, Hunan, 중국, 410005
- Hunan Provincial People's Hospital ( Site 0113)
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Changsha, Hunan, 중국, 410013
- Hunan Cancer Hospital ( Site 0096)
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Jiangsu
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Suzhou, Jiangsu, 중국, 215006
- The First Affiliated Hospital of Soochow University ( Site 0120)
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Jiangxi
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Nanchang, Jiangxi, 중국, 330029
- Jiangxi Provincial Cancer Hospital-Cancer Hospital ( Site 0134)
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Shaanxi
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Xi'an, Shaanxi, 중국, 710100
- Xi'an International Medical Center Hospital ( Site 0860)
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Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 200028
- The Third Affiliated Hospital of the PLA Navy Medical University ( Site 0123)
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Shanghai, Shanghai Municipality, 중국, 200032
- Fudan University Shanghai Cancer Center ( Site 0106)
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Shanghai, Shanghai Municipality, 중국, 200032
- Zhongshan Hospital Fudan University ( Site 0084)
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Shanxi
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Xi’an, Shanxi, 중국, 710048
- The First Affiliated Hospital of Xi an Jiaotong University ( Site 0108)
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Sichuan
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Chengdu, Sichuan, 중국, 610041
- West China Hospital of Sichuan University ( Site 0119)
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Suining, Sichuan, 중국, 629000
- Suining Central Hospital ( Site 0857)
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Tianjin Municipality
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Tianjin, Tianjin Municipality, 중국, 300060
- Tianjin Medical University Cancer Institute & Hospital ( Site 0098)
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Tianjin, Tianjin Municipality, 중국, 300170
- Tianjin Third Central Hospital ( Site 0861)
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Yunnan
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Kunming, Yunnan, 중국, 650200
- The First Hospital of Kunming ( Site 0124)
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Zhejiang
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Hangzhou, Zhejiang, 중국, 310009
- 2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0110)
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Hangzhou, Zhejiang, 중국, 310018
- Sir Run Run Shaw Hospital ( Site 0094)
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Hangzhou, Zhejiang, 중국, 310022
- Zhejiang Cancer Hospital ( Site 0103)
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Ningbo, Zhejiang, 중국, 315048
- Ningbo Medical Center LiHuili Hospital ( Site 0132)
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Araucania
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Temuco, Araucania, 칠레, 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, 칠레, 7560908
- Centro de Oncología de Precisión-Oncology ( Site 0068)
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Santiago, Region M. de Santiago, 칠레, 8330024
- Centro de Cancer Nuestra Senora de la Esperanza ( Site 0065)
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Santiago, Region M. de Santiago, 칠레, 8420383
- Bradfordhill ( Site 0066)
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Antioquia
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Medellín, Antioquia, 콜롬비아, 050034
- Hospital Pablo Tobon Uribe ( Site 0145)
-
-
Bogota D.C.
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Bogotá, Bogota D.C., 콜롬비아, 110221
- Administradora Country S.A. ( Site 0137)
-
-
Santander Department
-
Piedecuesta, Santander Department, 콜롬비아, 681017
- Fundacion Cardiovascular de Colombia ( Site 0136)
-
-
Valle del Cauca Department
-
Cali, Valle del Cauca Department, 콜롬비아, 760032
- Fundación Valle del Lili ( Site 0140)
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-
-
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Bangkok
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Bangkok, Bangkok, 태국, 10330
- Chulalongkorn University ( Site 0627)
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Bangkok, Bangkok, 태국, 10400
- Ramathibodi Hospital, Mahidol University ( Site 0628)
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Bangkok, Bangkok, 태국, 10700
- Faculty of Medicine Siriraj Hospital ( Site 0629)
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-
-
-
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Ankara, 터키 (Türkiye), 06230
- Hacettepe University Medical Faculty ( Site 0653)
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Ankara, 터키 (Türkiye), 06800
- Ankara City Hospital-Medical Oncology ( Site 0661)
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Edirne, 터키 (Türkiye), 22030
- Trakya University Medical Faculty Balkan Oncology Hospital ( Site 0648)
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Istanbul, 터키 (Türkiye), 34093
- Bezmialem Vakf Üniversitesi-Oncology ( Site 0660)
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Izmir, 터키 (Türkiye), 35100
- Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 0654)
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Izmir, 터키 (Türkiye), 35575
- I.E.U. Medical Point Hastanesi ( Site 0649)
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Konya, 터키 (Türkiye), 42080
- Konya Necmettin Erbakan University Medical Faculty ( Site 0652)
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Malatya, 터키 (Türkiye), 44280
- Inonu Universitesi Medical Fakultesi ( Site 0650)
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-
-
-
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Coimbra, 포르투갈, 3000-075
- Centro Hospitalar e Universitario de Coimbra ( Site 0502)
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Lisbon, 포르투갈, 1169-050
- Unidade Local de Saude de São José - Hospital de Santo Antonio dos Capuchos ( Site 0505)
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Porto, 포르투갈, 4099-001
- Centro Hospitalar do Porto, E.P.E. - Hospital Geral de Sto. Antonio ( Site 0504)
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Porto, 포르투갈, 4200-072
- Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0503)
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Porto, 포르투갈, 4200-319
- Centro Hospitalar de Sao Joao. EPE - Hospital de Sao Joao ( Site 0501)
-
-
-
-
-
Hato Rey, 푸에르토 리코, 00917
- Puerto Rico Medical Research Center LLC ( Site 0523)
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Ponce, 푸에르토 리코, 00717
- Ad-Vance Medical Research LLC ( Site 0527)
-
San Juan, 푸에르토 리코, 00921-3201
- VA Caribbean Healthcare System ( Site 0524)
-
San Juan, 푸에르토 리코, 00927
- FDI Clinical Research ( Site 0522)
-
-
-
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Auvergne
-
Lyon, Auvergne, 프랑스, 69004
- Hopital de la Croix-Rousse ( Site 0193)
-
-
Bouches-du-Rhone
-
Marseille, Bouches-du-Rhone, 프랑스, 13005
- Hopital de la Timone ( Site 0188)
-
-
Gironde
-
Pessac, Gironde, 프랑스, 33604
- CHU Bordeaux Haut-Leveque ( Site 0185)
-
-
Meurthe-et-Moselle
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Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 프랑스, 54500
- C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 0180)
-
-
Val-de-Marne
-
Créteil, Val-de-Marne, 프랑스, 94000
- A.P.H. Paris, Hopital Henri Mondor ( Site 0179)
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Villejuif, Val-de-Marne, 프랑스, 94800
- Hopital Paul Brousse ( Site 0182)
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-
-
-
-
Budapest, 헝가리, 1085
- Semmelweis University ( Site 0264)
-
-
Somogy County
-
Kaposvár, Somogy County, 헝가리, 7400
- Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 0267)
-
-
Zala County
-
Zalaegerszeg, Zala County, 헝가리, 8900
- Zala Megyei Szent Rafael Korhaz ( Site 0265)
-
-
-
-
New South Wales
-
Kogarah, New South Wales, 호주, 2217
- St George Hospital ( Site 0005)
-
Westmead, New South Wales, 호주, 2145
- Westmead Hospital-Gastroenterology & Hepatology ( Site 0009)
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Queensland
-
Brisbane, Queensland, 호주, 4102
- Princess Alexandra Hospital ( Site 0006)
-
-
Victoria
-
Heidelberg, Victoria, 호주, 3084
- Austin Health ( Site 0008)
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Melbourne, Victoria, 호주, 3004
- Alfred Health ( Site 0004)
-
-
Western Australia
-
Perth, Western Australia, 호주, 6000
- Royal Perth Hospital ( Site 0002)
-
-
-
-
-
Shatin, 홍콩
- Prince of Wales Hospital ( Site 0242)
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
설명
포함 기준:
- 방사선학, 조직학 또는 세포학에 의해 확인된 HCC 진단이 있음
- HCC가 간에 국한되어 있으며 치유적 치료를 받을 수 없음
- C형 간염 바이러스(HCV)를 가진 참가자는 연구 개입을 시작하기 최소 1개월 전에 치료를 완료한 경우 자격이 있습니다.
- B형 간염 바이러스(HBV)를 가진 참가자는 자격이 있습니다.
- 항고혈압제를 사용하거나 사용하지 않고 적절하게 혈압을 조절했습니다.
- 적절한 장기 기능을 가지고 있습니다.
제외 기준:
- 현재 간 이식 후보
- 지난 6개월 이내에 위출혈이 있었던 경우
- 약물로 조절되지 않는 복수가 있음
- 울혈성 심부전과 같은 연구 개입의 첫 번째 투여 후 12개월 이내에 심각한 심혈관 장애가 있음
- 치유되지 않는 심각한 상처, 궤양 또는 골절이 있는 경우
- 기존 간 병변에 국소 치료를 받은 경우
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 렌바티닙 + 펨브롤리주맙 + TACE
참가자는 렌바티닙, 펨브롤리주맙 및 TACE의 조합을 받게 됩니다.
렌바티닙은 12mg(선별 체중이 ≥60kg인 참가자의 경우) 또는 8mg(선별 체중이 있는 참가자의 경우)으로 투여됩니다.
|
12mg(선별 체중이 ≥60kg인 참가자의 경우) 또는 8mg(선별 체중이 있는 참가자의 경우) 투여
다른 이름들:
6주마다 1회(Q6W) 400mg의 용량으로 IV 주입을 통해 투여됩니다.
다른 이름들:
화학요법제 및 색전제(들)의 백그라운드 절차로 수행됩니다.
|
|
활성 비교기: 경구 위약 + IV 위약 + TACE
참가자는 렌바티닙과 일치하는 경구 위약, 펨브롤리주맙과 일치하는 IV 위약 및 TACE의 조합을 받게 됩니다.
렌바티닙과 일치하는 경구용 위약은 최대 2년(~35주기) 동안 각 21일 주기 동안 하루에 한 번 투여되며, 펨브롤리주맙과 일치하는 IV 위약은 최대 6주마다(Q6W) 투여됩니다. ~ 2년(~17회 용량).
참가자는 화학 요법 및 색전제의 배경 절차로 TACE를 받게 됩니다.
|
화학요법제 및 색전제(들)의 백그라운드 절차로 수행됩니다.
각 21일 주기 동안 1일 1회 경구 캡슐을 통해 투여되는 렌바티닙 일치 위약.
6주마다 1회(Q6W) IV 주입을 통해 투여되는 Pembrolizumab-matching 위약.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
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)
기간: 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.
|
Up to approximately 43.5 Months
|
|
Overall Survival (OS)
기간: Up to approximately 61.7 Months
|
OS was defined as the time from randomization to death due to any cause.
|
Up to approximately 61.7 Months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
PFS Per Modified RECIST (mRECIST) as Assessed by BICR
기간: 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.
|
Up to approximately 61.7 Months
|
|
Objective Response Rate (ORR) Per mRECIST as Assessed by BICR
기간: Up to approximately 61.7 Months
|
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.
|
Up to approximately 61.7 Months
|
|
Disease Control Rate (DCR) Per mRECIST as Assessed by BICR
기간: 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.
|
Up to approximately 61.7 Months
|
|
Duration of Response (DOR) Per mRECIST as Assessed by BICR
기간: Up to approximately 61.7 Months
|
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.
|
Up to approximately 61.7 Months
|
|
Time-To-Progression (TTP) Per mRECIST as Assessed by BICR
기간: 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.
|
Up to approximately 61.7 Months
|
|
Number of Participants Who Experienced At Least One Adverse Event (AE)
기간: Up to approximately 71.1 Months
|
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.
|
Up to approximately 71.1 Months
|
|
Percentage of Participants Who Experience At Least One Serious Adverse Event (SAE)
기간: 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.
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.
|
Up to approximately 71.1 Months
|
|
Number of Participants Who Experience At Least One Hepatic Event of Clinical Interest (ECI)
기간: 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.
|
Up to approximately 71.1 Months
|
|
Number of Participants Who Discontinue Study Treatment Due to an AE
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2020년 5월 22일
기본 완료 (실제)
2025년 8월 19일
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연구 기록 업데이트
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추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 7902-012
- 2019 (미국 NIH 보조금/계약: Chief Medical Office (CMO) Alberta Health Services)
- MK-7902-012 (기타 식별자: MSD Protocol Number)
- LEAP-012 (기타 식별자: MSD)
- E7080-G000-318 (기타 식별자: Eisai Protocol Number)
- 205286 (레지스트리 식별자: JAPIC-CTI)
- 2019-002345-37 (EudraCT 번호)
- 2022-502116-36-00 (레지스트리 식별자: EU CT)
- U1111-1283-3439 (레지스트리 식별자: UTN)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .