Veiligheid en werkzaamheid van lenvatinib (E7080/MK-7902) met pembrolizumab (MK-3475) in combinatie met transarteriële chemo-embolisatie (TACE) bij deelnemers met ongeneeslijk/niet-gemetastaseerd hepatocellulair carcinoom (MK-7902-012/E7080-G000-318/ LEAP-012)
1 september 2026 bijgewerkt door: Merck Sharp & Dohme LLC
Een multicenter, gerandomiseerde, dubbelblinde, actief gecontroleerde, klinische fase 3-studie ter evaluatie van de veiligheid en werkzaamheid van lenvatinib (E7080/MK-7902) met pembrolizumab (MK-3475) in combinatie met transarteriële chemo-embolisatie (TACE) versus TACE in Deelnemers met ongeneeslijk/niet-gemetastaseerd hepatocellulair carcinoom (LEAP-012)
Het doel van deze studie is het evalueren van de werkzaamheid en veiligheid van lenvatinib en pembrolizumab in combinatie met TACE versus TACE plus orale en intraveneuze (IV) placebo's bij deelnemers met ongeneeslijk, niet-gemetastaseerd hepatocellulair carcinoom (HCC).
De primaire hypothesen zijn dat pembrolizumab plus lenvatinib in combinatie met TACE superieur is aan placebo plus TACE met betrekking tot progressievrije overleving (PFS) en totale overleving (OS).
Studie Overzicht
Toestand
Beëindigd
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
480
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
New South Wales
-
Kogarah, New South Wales, Australië, 2217
- St George Hospital ( Site 0005)
-
Westmead, New South Wales, Australië, 2145
- Westmead Hospital-Gastroenterology & Hepatology ( Site 0009)
-
-
Queensland
-
Brisbane, Queensland, Australië, 4102
- Princess Alexandra Hospital ( Site 0006)
-
-
Victoria
-
Heidelberg, Victoria, Australië, 3084
- Austin Health ( Site 0008)
-
Melbourne, Victoria, Australië, 3004
- Alfred Health ( Site 0004)
-
-
Western Australia
-
Perth, Western Australia, Australië, 6000
- Royal Perth Hospital ( Site 0002)
-
-
-
-
-
São Paulo, Brazilië, 01509-900
- A.C. Camargo Cancer Center ( Site 0054)
-
-
Rio Grande do Norte
-
Natal, Rio Grande do Norte, Brazilië, 59075-740
- Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0057)
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brazilië, 91350-200
- Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0056)
-
-
Santa Catarina
-
Blumenau, Santa Catarina, Brazilië, 89010-340
- Clinica de Oncologia Reichow ( Site 0052)
-
-
São Paulo
-
Barretos, São Paulo, Brazilië, 14784-400
- Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 0058)
-
Jaú, São Paulo, Brazilië, 17210-120
- Fundacao Dr Amaral Carvalho ( Site 0050)
-
São José do Rio Preto, São Paulo, Brazilië, 15090-000
- Hospital de Base de Sao Jose de Rio Preto ( Site 0043)
-
São Paulo, São Paulo, Brazilië, 01323-001
- BP - A Beneficencia Portuguesa de São Paulo ( Site 0046)
-
-
-
-
Araucania
-
Temuco, Araucania, Chili, 4800827
- Centro Investigación del Cáncer James Lind ( Site 0064)
-
-
Region M. de Santiago
-
Santiago, Region M. de Santiago, Chili, 7560908
- Centro de Oncología de Precisión-Oncology ( Site 0068)
-
Santiago, Region M. de Santiago, Chili, 8330024
- Centro de Cancer Nuestra Senora de la Esperanza ( Site 0065)
-
Santiago, Region M. de Santiago, Chili, 8420383
- Bradfordhill ( Site 0066)
-
-
-
-
Anhui
-
Heifei, Anhui, China, 230001
- Anhui Provincial Hospital ( Site 0092)
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, China, 100142
- Beijing Cancer Hospital ( Site 0099)
-
Beijing, Beijing Municipality, China, 100142
- Beijing Cancer Hospital ( Site 0105)
-
Beijing, Beijing Municipality, China, 100730
- Peking Union Medical College Hospital ( Site 0087)
-
-
Chongqing Municipality
-
Chongqing, Chongqing Municipality, China, 400042
- Chinese People s Liberation Army Army Characteristic Medical Center ( Site 0117)
-
Chongqing, Chongqing Municipality, China, 404000
- Chongqing University Three Gorges Hospital ( Site 0859)
-
-
Fujian
-
Fuzhou, Fujian, China, 350014
- Fujian Provincial Cancer Hospital ( Site 0085)
-
Fuzhou, Fujian, China, 350014
- The First Affiliated Hospital of Fujian Medical University ( Site 0089)
-
Fuzhou, Fujian, China, 350008
- Mengchao Hepatobiliary Hospital of Fujian Medical University ( Site 0121)
-
Xiamen, Fujian, China, 361015
- Zhongshan Hospital Fudan University (Xiamen Branch) ( Site 0133)
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510000
- Zhujiang Hospital of Southern Medical University ( Site 0115)
-
Guangzhou, Guangdong, China, 510080
- Guangdong Provincial People s Hospital ( Site 0100)
-
Guangzhou, Guangdong, China, 510515
- NANFANG HOSPITAL SOUTHERN MEDICAL UNIVERSITY ( Site 0088)
-
Guangzhou, Guangdong, China, 510700
- SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 0128)
-
Zhuhai, Guangdong, China, 519000
- Jinan University - Zhuhai People's Hospital-Intervention Department ( Site 0856)
-
-
Guangxi
-
Nanning, Guangxi, China, 530021
- Guangxi Medical University Affiliated Tumor Hospital-Hepatological surgery ( Site 0862)
-
-
Hainan
-
Haikou, Hainan, China, 570311
- Hainan General Hospital ( Site 0112)
-
-
Heilongjiang
-
Harbin, Heilongjiang, China, 150081
- Harbin Medical University Cancer Hospital ( Site 0090)
-
-
Henan
-
Zhengzhou, Henan, China, 450008
- Henan Cancer Hospital ( Site 0114)
-
-
Hubei
-
Wuhan, Hubei, China, 430079
- Hubei Cancer Hospital ( Site 0101)
-
Wuhan, Hubei, China, 430000
- Tongji Hospital Tongji Medical,Science & Technology ( Site 0126)
-
-
Hunan
-
Changsha, Hunan, China, 410005
- Hunan Provincial People's Hospital ( Site 0113)
-
Changsha, Hunan, China, 410013
- Hunan Cancer Hospital ( Site 0096)
-
-
Jiangsu
-
Suzhou, Jiangsu, China, 215006
- The First Affiliated Hospital of Soochow University ( Site 0120)
-
-
Jiangxi
-
Nanchang, Jiangxi, China, 330029
- Jiangxi Provincial Cancer Hospital-Cancer Hospital ( Site 0134)
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710100
- Xi'an International Medical Center Hospital ( Site 0860)
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, China, 200028
- The Third Affiliated Hospital of the PLA Navy Medical University ( Site 0123)
-
Shanghai, Shanghai Municipality, China, 200032
- Fudan University Shanghai Cancer Center ( Site 0106)
-
Shanghai, Shanghai Municipality, China, 200032
- Zhongshan Hospital Fudan University ( Site 0084)
-
-
Shanxi
-
Xi’an, Shanxi, China, 710048
- The First Affiliated Hospital of Xi an Jiaotong University ( Site 0108)
-
-
Sichuan
-
Chengdu, Sichuan, China, 610041
- West China Hospital of Sichuan University ( Site 0119)
-
Suining, Sichuan, China, 629000
- Suining Central Hospital ( Site 0857)
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, China, 300060
- Tianjin Medical University Cancer Institute & Hospital ( Site 0098)
-
Tianjin, Tianjin Municipality, China, 300170
- Tianjin Third Central Hospital ( Site 0861)
-
-
Yunnan
-
Kunming, Yunnan, China, 650200
- The First Hospital of Kunming ( Site 0124)
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310009
- 2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0110)
-
Hangzhou, Zhejiang, China, 310018
- Sir Run Run Shaw Hospital ( Site 0094)
-
Hangzhou, Zhejiang, China, 310022
- Zhejiang Cancer Hospital ( Site 0103)
-
Ningbo, Zhejiang, China, 315048
- Ningbo Medical Center LiHuili Hospital ( Site 0132)
-
-
-
-
Antioquia
-
Medellín, Antioquia, Colombia, 050034
- Hospital Pablo Tobon Uribe ( Site 0145)
-
-
Bogota D.C.
-
Bogotá, Bogota D.C., Colombia, 110221
- Administradora Country S.A. ( Site 0137)
-
-
Santander Department
-
Piedecuesta, Santander Department, Colombia, 681017
- Fundacion Cardiovascular de Colombia ( Site 0136)
-
-
Valle del Cauca Department
-
Cali, Valle del Cauca Department, Colombia, 760032
- Fundación Valle del Lili ( Site 0140)
-
-
-
-
Capital Region
-
Herlev, Capital Region, Denemarken, 2730
- Herlev Hospital ( Site 0170)
-
-
Central Jutland
-
Aarhus N, Central Jutland, Denemarken, 8200
- Aarhus Universitets hospital ( Site 0175)
-
-
Region Syddanmark
-
Odense, Region Syddanmark, Denemarken, 5000
- Odense Universitetshospital ( Site 0160)
-
-
-
-
-
Berlin, Duitsland, 13353
- Charite - Universitaetsmedizin ( Site 0204)
-
Hamburg, Duitsland, 20246
- Universitaetsklinikum Hamburg-Eppendorf ( Site 0207)
-
-
Baden-Wurttemberg
-
Freiburg im Breisgau, Baden-Wurttemberg, Duitsland, 79106
- Universitaetsklinikum Freiburg ( Site 0199)
-
-
Hesse
-
Frankfurt am Main, Hesse, Duitsland, 60488
- Krankenhaus Nord-West GmbH ( Site 0208)
-
-
Lower Saxony
-
Hanover, Lower Saxony, Duitsland, 30625
- Medizinische Hochschule Hannover ( Site 0200)
-
-
North Rhine-Westphalia
-
Bonn, North Rhine-Westphalia, Duitsland, 53127
- Universitaetsklinikum Bonn ( Site 0203)
-
-
Saxony
-
Leipzig, Saxony, Duitsland, 04103
- Universitaetsklinikum Leipzig ( Site 0202)
-
-
Saxony-Anhalt
-
Halle, Saxony-Anhalt, Duitsland, 06120
- Universitaetsklinikum Halle ( Site 0213)
-
-
Schleswig-Holstein
-
Lübeck, Schleswig-Holstein, Duitsland, 23538
- Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0215)
-
-
-
-
Auvergne
-
Lyon, Auvergne, Frankrijk, 69004
- Hopital de la Croix-Rousse ( Site 0193)
-
-
Bouches-du-Rhone
-
Marseille, Bouches-du-Rhone, Frankrijk, 13005
- Hopital de la Timone ( Site 0188)
-
-
Gironde
-
Pessac, Gironde, Frankrijk, 33604
- CHU Bordeaux Haut-Leveque ( Site 0185)
-
-
Meurthe-et-Moselle
-
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, Frankrijk, 54500
- C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 0180)
-
-
Val-de-Marne
-
Créteil, Val-de-Marne, Frankrijk, 94000
- A.P.H. Paris, Hopital Henri Mondor ( Site 0179)
-
Villejuif, Val-de-Marne, Frankrijk, 94800
- Hopital Paul Brousse ( Site 0182)
-
-
-
-
-
Budapest, Hongarije, 1085
- Semmelweis University ( Site 0264)
-
-
Somogy County
-
Kaposvár, Somogy County, Hongarije, 7400
- Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 0267)
-
-
Zala County
-
Zalaegerszeg, Zala County, Hongarije, 8900
- Zala Megyei Szent Rafael Korhaz ( Site 0265)
-
-
-
-
-
Shatin, Hongkong
- Prince of Wales Hospital ( Site 0242)
-
-
-
-
-
Dublin, Ierland, D04 T6F4
- St Vincents University Hospital ( Site 0690)
-
-
-
-
-
Afula, Israël, 1834111
- Emek Medical Center ( Site 0307)
-
Haifa, Israël, 3109601
- Rambam Health Care Campus-Oncology Division ( Site 0305)
-
Jerusaelm, Israël, 9112001
- Hadassah Ein Karem Jerusalem ( Site 0303)
-
Petah Tikva, Israël, 4941 492
- Rabin Medical Center ( Site 0304)
-
Tel Aviv, Israël, 6423906
- Sourasky Medical Center ( Site 0306)
-
-
-
-
-
Brescia, Italië, 25123
- Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 0334)
-
Milan, Italië, 20122
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico ( Site 0325)
-
Naples, Italië, 80131
- Az Osp di Rilievo Nazionale A. Cardarelli ( Site 0329)
-
Ravenna, Italië, 48121
- Azienda USL della Romagna-Dipartimento di Oncologia ed Ematologia ( Site 0332)
-
Roma, Italië, 00168
- Policlinico Universitario -Agostino Gemelli ( Site 0328)
-
-
Campania
-
Naples, Campania, Italië, 80147
- Ospedale del Mare ( Site 0327)
-
-
Milano
-
Milan, Milano, Italië, 20162
- ASST Grande Ospedale Metropolitano Niguarda-Oncologia Falck ( Site 0331)
-
-
Piedmont
-
Turin, Piedmont, Italië, 10128
- Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 0333)
-
-
Sicily
-
Messina, Sicily, Italië, 98124
- AOU Policlinico G. Martino ( Site 0324)
-
-
-
-
-
Chiba, Japan, 260-8677
- Chiba University Hospital ( Site 0346)
-
Fukuoka, Japan, 8108563
- National Hospital Organization Kyushu Medical Center ( Site 0361)
-
Hiroshima, Japan, 734-8551
- Hiroshima University Hospital ( Site 0360)
-
Kumamoto, Japan, 860-8556
- Kumamoto University Hospital ( Site 0372)
-
Kyoto, Japan, 602-8566
- University Hospital,Kyoto Prefectural University of Medicine ( Site 0367)
-
Osaka, Japan, 541-8567
- Osaka International Cancer Institute ( Site 0357)
-
Osaka, Japan, 543-8555
- Japanese Red Cross Osaka Hospital ( Site 0356)
-
Saga, Japan, 840-8571
- Saga-Ken Medical Centre Koseikan ( Site 0363)
-
Tokyo, Japan, 105-8470
- Toranomon Hospital ( Site 0349)
-
Tokyo, Japan, 113-0033
- Juntendo University Hospital ( Site 0371)
-
Tokyo, Japan, 113-8655
- The University of Tokyo Hospital ( Site 0348)
-
-
Chiba
-
Kashiwa, Chiba, Japan, 277-8577
- National Cancer Center Hospital East ( Site 0347)
-
-
Ehime
-
Tōon, Ehime, Japan, 791-0295
- Ehime University Hospital ( Site 0368)
-
-
Fukuoka
-
Kurume, Fukuoka, Japan, 830-0011
- Kurume University Hospital ( Site 0362)
-
-
Hokkaido
-
Sapporo, Hokkaido, Japan, 060-0033
- Sapporo Kosei General Hospital ( Site 0345)
-
-
Ishikawa-ken
-
Kanazawa, Ishikawa-ken, Japan, 920-8641
- Kanazawa University Hospital ( Site 0354)
-
-
Kagawa-ken
-
Takamatsu, Kagawa-ken, Japan, 760-8557
- Kagawa Prefectural Central Hospital ( Site 0364)
-
-
Kanagawa
-
Kawasaki, Kanagawa, Japan, 213-8587
- Toranomon Hospital Kajigaya ( Site 0369)
-
Yokohama, Kanagawa, Japan, 232-0024
- Yokohama City University Medical Center ( Site 0351)
-
Yokohama, Kanagawa, Japan, 241-8515
- Kanagawa Cancer Center ( Site 0352)
-
-
Nara
-
Kashihara, Nara, Japan, 634-8522
- Nara Medical University Hospital ( Site 0359)
-
-
Osaka
-
Sayama, Osaka, Japan, 589-8511
- Kindai University Hospital ( Site 0358)
-
-
Saitama
-
Iruma-gun, Saitama, Japan, 350-0495
- Saitama Medical University Hospital ( Site 0370)
-
-
Shizuoka
-
Suntogun, Shizuoka, Japan, 411-8777
- Shizuoka Cancer Center ( Site 0365)
-
-
Tochigi
-
Shimotsuke, Tochigi, Japan, 329-0498
- Jichi Medical University Hospital ( Site 0353)
-
-
-
-
-
Utrecht, Nederland, 3584 CX
- Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 0441)
-
-
Limburg
-
Maastricht, Limburg, Nederland, 6229 HX
- Maastricht University Medical Centre ( Site 0440)
-
-
North Holland
-
Amsterdam, North Holland, Nederland, 1105 AZ
- AMC ( Site 0438)
-
-
South Holland
-
Leiden, South Holland, Nederland, 2333 ZA
- Leids Universitair Medisch Centrum-Medical Oncology ( Site 0442)
-
Rotterdam, South Holland, Nederland, 3015 GD
- Erasmus University Medical Center ( Site 0439)
-
-
-
-
-
Auckland, Nieuw-Zeeland, 1023
- Auckland City Hospital ( Site 0459)
-
-
-
-
-
Oslo, Noorwegen, 0450
- Oslo Universitetssykehus Ullevål ( Site 0500)
-
-
-
-
Kharkiv Oblast
-
Kharkiv, Kharkiv Oblast, Oekraïne, 61070
- Communal non profit enterprise Regional Clinical Oncology Center ( Site 0669)
-
-
-
-
-
Coimbra, Portugal, 3000-075
- Centro Hospitalar e Universitario de Coimbra ( Site 0502)
-
Lisbon, Portugal, 1169-050
- Unidade Local de Saude de São José - Hospital de Santo Antonio dos Capuchos ( Site 0505)
-
Porto, Portugal, 4099-001
- Centro Hospitalar do Porto, E.P.E. - Hospital Geral de Sto. Antonio ( Site 0504)
-
Porto, Portugal, 4200-072
- Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0503)
-
Porto, Portugal, 4200-319
- Centro Hospitalar de Sao Joao. EPE - Hospital de Sao Joao ( Site 0501)
-
-
-
-
-
Hato Rey, Puerto Rico, 00917
- Puerto Rico Medical Research Center LLC ( Site 0523)
-
Ponce, Puerto Rico, 00717
- Ad-Vance Medical Research LLC ( Site 0527)
-
San Juan, Puerto Rico, 00921-3201
- VA Caribbean Healthcare System ( Site 0524)
-
San Juan, Puerto Rico, 00927
- FDI Clinical Research ( Site 0522)
-
-
-
-
-
Madrid, Spanje, 28007
- Hospital General Universitario Gregorio Maranon ( Site 0598)
-
Madrid, Spanje, 28034
- Hospital Ramon y Cajal ( Site 0593)
-
Madrid, Spanje, 28040
- Hospital Clinico San Carlos ( Site 0597)
-
Seville, Spanje, 41013
- Hospital Virgen del Rocio ( Site 0591)
-
-
Madrid
-
Majadahonda, Madrid, Spanje, 28222
- Hospital Universitario Puerta de Hierro ( Site 0596)
-
-
Valenciana, Comunitat
-
Valencia, Valenciana, Comunitat, Spanje, 46014
- Hospital General Universitario de Valencia ( Site 0595)
-
-
-
-
-
Kaohsiung City, Taiwan, 807
- Kaohsiung Medical University Hospital ( Site 0611)
-
Taichung, Taiwan, 40447
- China Medical University Hospital-Surgical Department ( Site 0610)
-
Taichung, Taiwan, 407
- Taichung Veterans General Hospital ( Site 0613)
-
Tainan, Taiwan, 70457
- National Cheng Kung University Hospital ( Site 0608)
-
Taipei, Taiwan, 10002
- National Taiwan University Hospital ( Site 0606)
-
Taipei, Taiwan, 112201
- Taipei Veterans General Hospital-Division of Gastroenterology & Hepatology, Department of Medicine ( Site 0612)
-
Taoyuan, Taiwan, 333
- Chang Gung Medical Foundation. Linkou ( Site 0607)
-
-
Kaohsiung
-
Kaohsiung City, Kaohsiung, Taiwan, 833
- Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0609)
-
-
-
-
Bangkok
-
Bangkok, Bangkok, Thailand, 10330
- Chulalongkorn University ( Site 0627)
-
Bangkok, Bangkok, Thailand, 10400
- Ramathibodi Hospital, Mahidol University ( Site 0628)
-
Bangkok, Bangkok, Thailand, 10700
- Faculty of Medicine Siriraj Hospital ( Site 0629)
-
-
-
-
-
Ankara, Turkije (Türkiye), 06230
- Hacettepe University Medical Faculty ( Site 0653)
-
Ankara, Turkije (Türkiye), 06800
- Ankara City Hospital-Medical Oncology ( Site 0661)
-
Edirne, Turkije (Türkiye), 22030
- Trakya University Medical Faculty Balkan Oncology Hospital ( Site 0648)
-
Istanbul, Turkije (Türkiye), 34093
- Bezmialem Vakf Üniversitesi-Oncology ( Site 0660)
-
Izmir, Turkije (Türkiye), 35100
- Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 0654)
-
Izmir, Turkije (Türkiye), 35575
- I.E.U. Medical Point Hastanesi ( Site 0649)
-
Konya, Turkije (Türkiye), 42080
- Konya Necmettin Erbakan University Medical Faculty ( Site 0652)
-
Malatya, Turkije (Türkiye), 44280
- Inonu Universitesi Medical Fakultesi ( Site 0650)
-
-
-
-
London, City of
-
London, London, City of, Verenigd Koninkrijk, EC1A 7BE
- Barts Health NHS Trust ( Site 0692)
-
London, London, City of, Verenigd Koninkrijk, SW3 6JJ
- Royal Marsden NHS Foundation Trust ( Site 0694)
-
Sutton, London, City of, Verenigd Koninkrijk, SM2 5PT
- Royal Marsden NHS Trust ( Site 0693)
-
-
-
-
Arizona
-
Tucson, Arizona, Verenigde Staten, 85711
- Arizona Oncology Associates PC- HOPE ( Site 0770)
-
-
California
-
La Jolla, California, Verenigde Staten, 92037
- Scripps Clinic Torrey Pines ( Site 0714)
-
Los Angeles, California, Verenigde Staten, 90033
- USC Norris Comprehensive Cancer Center ( Site 0717)
-
Los Angeles, California, Verenigde Staten, 90404
- UCLA Hematology/Oncology - Santa Monica ( Site 0720)
-
Orange, California, Verenigde Staten, 92868
- UC Irvine Health ( Site 0718)
-
-
Connecticut
-
New Haven, Connecticut, Verenigde Staten, 06510
- Yale Cancer Center ( Site 0724)
-
-
Florida
-
Tampa, Florida, Verenigde Staten, 33606
- Tampa General Hospital ( Site 0764)
-
-
Idaho
-
Boise, Idaho, Verenigde Staten, 83712
- Mountain States Tumor Institute ( Site 0773)
-
-
Iowa
-
Iowa City, Iowa, Verenigde Staten, 52242
- University of Iowa Hospital and Clinics ( Site 0729)
-
-
Kansas
-
Westwood, Kansas, Verenigde Staten, 66205
- University of Kansas Cancer Center ( Site 0731)
-
-
Kentucky
-
Louisville, Kentucky, Verenigde Staten, 40202
- University of Louisville ( Site 0757)
-
-
Louisiana
-
New Orleans, Louisiana, Verenigde Staten, 70112
- Tulane Medical Center ( Site 0787)
-
New Orleans, Louisiana, Verenigde Staten, 70112
- University Medical Center New Orleans ( Site 0733)
-
-
Michigan
-
Detroit, Michigan, Verenigde Staten, 48202
- Henry Ford Hospital-GI/Hepatology Research ( Site 0735)
-
-
Missouri
-
St Louis, Missouri, Verenigde Staten, 63110
- Saint Louis University ( Site 0769)
-
-
New Mexico
-
Albuquerque, New Mexico, Verenigde Staten, 87106
- University of New Mexico Comprehensive Cancer Center ( Site 0805)
-
-
New York
-
Lake Success, New York, Verenigde Staten, 11042
- Monter Cancer Center ( Site 0780)
-
New York, New York, Verenigde Staten, 10029
- Icahn School of Medicine at Mount Sinai ( Site 0744)
-
-
North Carolina
-
Winston-Salem, North Carolina, Verenigde Staten, 27157
- Wake Forest Baptist Health ( Site 0741)
-
-
Ohio
-
Cincinnati, Ohio, Verenigde Staten, 45219
- University of Cincinnati Medical Center ( Site 0791)
-
Columbus, Ohio, Verenigde Staten, 43210
- The Ohio State University Wexner Medical Center ( Site 0759)
-
Sylvania, Ohio, Verenigde Staten, 43560
- ProMedica Flower Hospital ( Site 0796)
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Verenigde Staten, 73104
- Stephenson Cancer Center ( Site 0745)
-
-
Oregon
-
Portland, Oregon, Verenigde Staten, 97239
- OHSU Center for Health & Healing ( Site 0746)
-
-
Pennsylvania
-
Hershey, Pennsylvania, Verenigde Staten, 17033-0850
- Penn State Hershey Medical Center ( Site 0766)
-
-
Texas
-
Houston, Texas, Verenigde Staten, 77030
- Houston Methodist Research Institute ( Site 0784)
-
-
West Virginia
-
Huntington, West Virginia, Verenigde Staten, 25701
- Edwards Comprehensive Cancer Center ( Site 0786)
-
-
-
-
-
Seoul, Zuid -Korea, 03080
- Seoul National University Hospital ( Site 0567)
-
Seoul, Zuid -Korea, 03722
- Severance Hospital Yonsei University Health System ( Site 0564)
-
Seoul, Zuid -Korea, 05505
- Asan Medical Center ( Site 0565)
-
Seoul, Zuid -Korea, 06351
- Samsung Medical Center ( Site 0566)
-
Seoul, Zuid -Korea, 06591
- The Catholic University of Korea St. Mary s Hospital ( Site 0571)
-
Seoul, Zuid -Korea, 08308
- Korea University Guro Hospital ( Site 0573)
-
-
Jeonranamdo
-
Hwasun, Jeonranamdo, Zuid -Korea, 58128
- Chonnam National University Hwasun Hospital ( Site 0572)
-
-
Kyonggi-do
-
Seongnam-si, Kyonggi-do, Zuid -Korea, 13620
- Seoul National University Bundang Hospital ( Site 0570)
-
-
Pusan-Kwangyokshi
-
Busan, Pusan-Kwangyokshi, Zuid -Korea, 49241
- Pusan National University Hospital ( Site 0568)
-
-
Taegu-Kwangyokshi
-
Daegu, Taegu-Kwangyokshi, Zuid -Korea, 41944
- Kyungpook National University Hospital ( Site 0569)
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusiecriteria:
- Heeft een diagnose van HCC bevestigd door radiologie, histologie of cytologie
- Heeft HCC gelokaliseerd in de lever en niet vatbaar voor curatieve behandeling
- Deelnemers met hepatitis C-virus (HCV) komen in aanmerking als de behandeling ten minste 1 maand voorafgaand aan de start van de studie-interventie is voltooid
- Deelnemers met het Hepatitis B-virus (HBV) komen in aanmerking
- Heeft een voldoende gecontroleerde bloeddruk met of zonder antihypertensiva
- Heeft een adequate orgaanfunctie
Uitsluitingscriteria:
- Is momenteel een kandidaat voor levertransplantatie
- Heeft in de afgelopen 6 maanden een maagbloeding gehad
- Heeft ascites die niet onder controle is met medicijnen
- Heeft significante cardiovasculaire stoornissen binnen 12 maanden na de eerste dosis studie-interventie, zoals congestief hartfalen
- Heeft een ernstige niet-genezende wond, zweer of botbreuk
- Locoregionale therapie heeft gekregen voor bestaande leverlaesies
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Lenvatinib plus Pembrolizumab plus TACE
Deelnemers krijgen een combinatie van lenvatinib, pembrolizumab en TACE.
Lenvatinib wordt toegediend in een dosis van 12 mg (voor deelnemers met een lichaamsgewicht van ≥ 60 kg) of 8 mg (voor deelnemers met een lichaamsgewicht van
|
Toegediend in een dosis van 12 mg (voor deelnemers met een lichaamsgewicht van ≥ 60 kg) of 8 mg (voor deelnemers met een lichaamsgewicht van
Andere namen:
Toegediend via intraveneuze infusie in een dosis van 400 mg eenmaal per 6 weken (Q6W).
Andere namen:
Uitgevoerd als achtergrondprocedure van chemotherapeutische en embolische middelen.
|
|
Actieve vergelijker: Oraal Placebo plus IV Placebo plus TACE
Deelnemers krijgen een combinatie van lenvatinib-matching orale placebo, pembrolizumab-matching IV placebo en TACE.
Lenvatinib-matchende orale placebo zal eenmaal daags worden toegediend tijdens elke cyclus van 21 dagen gedurende maximaal 2 jaar (~35 cycli) of langer met goedkeuring van de sponsor en pembrolizumab-matchende IV-placebo zal eenmaal per 6 weken worden toegediend (Q6W) gedurende maximaal tot 2 jaar (~ 17 doses).
Deelnemers zullen TACE ondergaan als een achtergrondprocedure van chemotherapeutische en embolische middelen.
|
Uitgevoerd als achtergrondprocedure van chemotherapeutische en embolische middelen.
Lenvatinib-matchende placebo eenmaal daags toegediend via orale capsules tijdens elke cyclus van 21 dagen.
Pembrolizumab-matching placebo eenmaal per 6 weken toegediend via intraveneuze infusie (Q6W).
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
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)
Tijdsspanne: 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)
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
PFS Per Modified RECIST (mRECIST) as Assessed by BICR
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Studie directeur: Medical Director, Merck Sharp & Dohme LLC
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
22 mei 2020
Primaire voltooiing (Werkelijk)
19 augustus 2025
Studie voltooiing (Werkelijk)
26 maart 2026
Studieregistratiedata
Eerst ingediend
27 januari 2020
Eerst ingediend dat voldeed aan de QC-criteria
27 januari 2020
Eerst geplaatst (Werkelijk)
29 januari 2020
Updates van studierecords
Laatste update geplaatst (Werkelijk)
3 september 2026
Laatste update ingediend die voldeed aan QC-criteria
1 september 2026
Laatst geverifieerd
1 september 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per site
- Neoplasmata
- Neoplasmata per histologisch type
- Neoplasmata van het spijsverteringsstelsel
- Ziekten van het spijsverteringsstelsel
- Lever Ziekten
- Neoplasmata, glandulair en epitheel
- Adenocarcinoom
- Lever neoplasmata
- Carcinoom
- Carcinoom, hepatocellulair
- Parkinson Disease 4, autosomaal dominant Lewy Body
- Antineoplastische middelen, immunologisch
- Immuun Checkpoint-remmers
- Antineoplastische middelen
- Moleculaire mechanismen van farmacologische werking
- Enzym-remmers
- Proteïnekinaseremmers
- pembrolizumab
- Lenvatinib
Andere studie-ID-nummers
- 7902-012
- 2019 (Subsidie/contract van de Amerikaanse NIH: Chief Medical Office (CMO) Alberta Health Services)
- MK-7902-012 (Andere identificatie: MSD Protocol Number)
- LEAP-012 (Andere identificatie: MSD)
- E7080-G000-318 (Andere identificatie: Eisai Protocol Number)
- 205286 (Register-ID: JAPIC-CTI)
- 2019-002345-37 (EudraCT-nummer)
- 2022-502116-36-00 (Register-ID: EU CT)
- U1111-1283-3439 (Register-ID: UTN)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .