難治性/非転移性肝細胞癌 (MK-7902-012/E7080-G000-318/ LEAP-012)
2026年9月1日 更新者：Merck Sharp & Dohme LLC
レンバチニブ (E7080/MK-7902) とペムブロリズマブ (MK-3475) の安全性と有効性を評価する第 III 相多施設無作為化二重盲検実薬対照臨床試験 (TACE) と TACE の比較難治性/非転移性肝細胞癌の参加者 (LEAP-012)
この研究の目的は、不治の非転移性肝細胞癌 (HCC) の参加者を対象に、レンバチニブとペムブロリズマブを TACE と併用した場合と、TACE と経口および静脈内 (IV) プラセボを併用した場合の有効性と安全性を評価することです。
主な仮説は、ペンブロリズマブ + レンバチニブと TACE の併用は、無増悪生存期間 (PFS) および全生存期間 (OS) に関して、プラセボ + TACE よりも優れているというものです。
調査の概要
研究の種類
介入
入学 (実際)
480
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Dublin、アイルランド、D04 T6F4
- St Vincents University Hospital ( Site 0690)
-
-
-
-
Arizona
-
Tucson、Arizona、アメリカ、85711
- Arizona Oncology Associates PC- HOPE ( Site 0770)
-
-
California
-
La Jolla、California、アメリカ、92037
- Scripps Clinic Torrey Pines ( Site 0714)
-
Los Angeles、California、アメリカ、90033
- USC Norris Comprehensive Cancer Center ( Site 0717)
-
Los Angeles、California、アメリカ、90404
- UCLA Hematology/Oncology - Santa Monica ( Site 0720)
-
Orange、California、アメリカ、92868
- UC Irvine Health ( Site 0718)
-
-
Connecticut
-
New Haven、Connecticut、アメリカ、06510
- Yale Cancer Center ( Site 0724)
-
-
Florida
-
Tampa、Florida、アメリカ、33606
- Tampa General Hospital ( Site 0764)
-
-
Idaho
-
Boise、Idaho、アメリカ、83712
- Mountain States Tumor Institute ( Site 0773)
-
-
Iowa
-
Iowa City、Iowa、アメリカ、52242
- University of Iowa Hospital and Clinics ( Site 0729)
-
-
Kansas
-
Westwood、Kansas、アメリカ、66205
- University of Kansas Cancer Center ( Site 0731)
-
-
Kentucky
-
Louisville、Kentucky、アメリカ、40202
- University of Louisville ( Site 0757)
-
-
Louisiana
-
New Orleans、Louisiana、アメリカ、70112
- Tulane Medical Center ( Site 0787)
-
New Orleans、Louisiana、アメリカ、70112
- University Medical Center New Orleans ( Site 0733)
-
-
Michigan
-
Detroit、Michigan、アメリカ、48202
- Henry Ford Hospital-GI/Hepatology Research ( Site 0735)
-
-
Missouri
-
St Louis、Missouri、アメリカ、63110
- Saint Louis University ( Site 0769)
-
-
New Mexico
-
Albuquerque、New Mexico、アメリカ、87106
- University of New Mexico Comprehensive Cancer Center ( Site 0805)
-
-
New York
-
Lake Success、New York、アメリカ、11042
- Monter Cancer Center ( Site 0780)
-
New York、New York、アメリカ、10029
- Icahn School of Medicine at Mount Sinai ( Site 0744)
-
-
North Carolina
-
Winston-Salem、North Carolina、アメリカ、27157
- Wake Forest Baptist Health ( Site 0741)
-
-
Ohio
-
Cincinnati、Ohio、アメリカ、45219
- University of Cincinnati Medical Center ( Site 0791)
-
Columbus、Ohio、アメリカ、43210
- The Ohio State University Wexner Medical Center ( Site 0759)
-
Sylvania、Ohio、アメリカ、43560
- ProMedica Flower Hospital ( Site 0796)
-
-
Oklahoma
-
Oklahoma City、Oklahoma、アメリカ、73104
- Stephenson Cancer Center ( Site 0745)
-
-
Oregon
-
Portland、Oregon、アメリカ、97239
- OHSU Center for Health & Healing ( Site 0746)
-
-
Pennsylvania
-
Hershey、Pennsylvania、アメリカ、17033-0850
- Penn State Hershey Medical Center ( Site 0766)
-
-
Texas
-
Houston、Texas、アメリカ、77030
- Houston Methodist Research Institute ( Site 0784)
-
-
West Virginia
-
Huntington、West Virginia、アメリカ、25701
- Edwards Comprehensive Cancer Center ( Site 0786)
-
-
-
-
London, City of
-
London、London, City of、イギリス、EC1A 7BE
- Barts Health NHS Trust ( Site 0692)
-
London、London, City of、イギリス、SW3 6JJ
- Royal Marsden NHS Foundation Trust ( Site 0694)
-
Sutton、London, City of、イギリス、SM2 5PT
- Royal Marsden NHS Trust ( Site 0693)
-
-
-
-
-
Afula、イスラエル、1834111
- Emek Medical Center ( Site 0307)
-
Haifa、イスラエル、3109601
- Rambam Health Care Campus-Oncology Division ( Site 0305)
-
Jerusaelm、イスラエル、9112001
- Hadassah Ein Karem Jerusalem ( Site 0303)
-
Petah Tikva、イスラエル、4941 492
- Rabin Medical Center ( Site 0304)
-
Tel Aviv、イスラエル、6423906
- Sourasky Medical Center ( Site 0306)
-
-
-
-
-
Brescia、イタリア、25123
- Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 0334)
-
Milan、イタリア、20122
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico ( Site 0325)
-
Naples、イタリア、80131
- Az Osp di Rilievo Nazionale A. Cardarelli ( Site 0329)
-
Ravenna、イタリア、48121
- Azienda USL della Romagna-Dipartimento di Oncologia ed Ematologia ( Site 0332)
-
Roma、イタリア、00168
- Policlinico Universitario -Agostino Gemelli ( Site 0328)
-
-
Campania
-
Naples、Campania、イタリア、80147
- Ospedale del Mare ( Site 0327)
-
-
Milano
-
Milan、Milano、イタリア、20162
- ASST Grande Ospedale Metropolitano Niguarda-Oncologia Falck ( Site 0331)
-
-
Piedmont
-
Turin、Piedmont、イタリア、10128
- Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 0333)
-
-
Sicily
-
Messina、Sicily、イタリア、98124
- AOU Policlinico G. Martino ( Site 0324)
-
-
-
-
Kharkiv Oblast
-
Kharkiv、Kharkiv Oblast、ウクライナ、61070
- Communal non profit enterprise Regional Clinical Oncology Center ( Site 0669)
-
-
-
-
-
Utrecht、オランダ、3584 CX
- Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 0441)
-
-
Limburg
-
Maastricht、Limburg、オランダ、6229 HX
- Maastricht University Medical Centre ( Site 0440)
-
-
North Holland
-
Amsterdam、North Holland、オランダ、1105 AZ
- AMC ( Site 0438)
-
-
South Holland
-
Leiden、South Holland、オランダ、2333 ZA
- Leids Universitair Medisch Centrum-Medical Oncology ( Site 0442)
-
Rotterdam、South Holland、オランダ、3015 GD
- Erasmus University Medical Center ( Site 0439)
-
-
-
-
New South Wales
-
Kogarah、New South Wales、オーストラリア、2217
- St George Hospital ( Site 0005)
-
Westmead、New South Wales、オーストラリア、2145
- Westmead Hospital-Gastroenterology & Hepatology ( Site 0009)
-
-
Queensland
-
Brisbane、Queensland、オーストラリア、4102
- Princess Alexandra Hospital ( Site 0006)
-
-
Victoria
-
Heidelberg、Victoria、オーストラリア、3084
- Austin Health ( Site 0008)
-
Melbourne、Victoria、オーストラリア、3004
- Alfred Health ( Site 0004)
-
-
Western Australia
-
Perth、Western Australia、オーストラリア、6000
- Royal Perth Hospital ( Site 0002)
-
-
-
-
Antioquia
-
Medellín、Antioquia、コロンビア、050034
- Hospital Pablo Tobon Uribe ( Site 0145)
-
-
Bogota D.C.
-
Bogotá、Bogota D.C.、コロンビア、110221
- Administradora Country S.A. ( Site 0137)
-
-
Santander Department
-
Piedecuesta、Santander Department、コロンビア、681017
- Fundacion Cardiovascular de Colombia ( Site 0136)
-
-
Valle del Cauca Department
-
Cali、Valle del Cauca Department、コロンビア、760032
- Fundación Valle del Lili ( Site 0140)
-
-
-
-
-
Madrid、スペイン、28007
- Hospital General Universitario Gregorio Maranon ( Site 0598)
-
Madrid、スペイン、28034
- Hospital Ramon y Cajal ( Site 0593)
-
Madrid、スペイン、28040
- Hospital Clinico San Carlos ( Site 0597)
-
Seville、スペイン、41013
- Hospital Virgen del Rocio ( Site 0591)
-
-
Madrid
-
Majadahonda、Madrid、スペイン、28222
- Hospital Universitario Puerta de Hierro ( Site 0596)
-
-
Valenciana, Comunitat
-
Valencia、Valenciana, Comunitat、スペイン、46014
- Hospital General Universitario de Valencia ( Site 0595)
-
-
-
-
Bangkok
-
Bangkok、Bangkok、タイ、10330
- Chulalongkorn University ( Site 0627)
-
Bangkok、Bangkok、タイ、10400
- Ramathibodi Hospital, Mahidol University ( Site 0628)
-
Bangkok、Bangkok、タイ、10700
- Faculty of Medicine Siriraj Hospital ( Site 0629)
-
-
-
-
Araucania
-
Temuco、Araucania、チリ、4800827
- Centro Investigación del Cáncer James Lind ( Site 0064)
-
-
Region M. de Santiago
-
Santiago、Region M. de Santiago、チリ、7560908
- Centro de Oncología de Precisión-Oncology ( Site 0068)
-
Santiago、Region M. de Santiago、チリ、8330024
- Centro de Cancer Nuestra Senora de la Esperanza ( Site 0065)
-
Santiago、Region M. de Santiago、チリ、8420383
- Bradfordhill ( Site 0066)
-
-
-
-
Capital Region
-
Herlev、Capital Region、デンマーク、2730
- Herlev Hospital ( Site 0170)
-
-
Central Jutland
-
Aarhus N、Central Jutland、デンマーク、8200
- Aarhus Universitets hospital ( Site 0175)
-
-
Region Syddanmark
-
Odense、Region Syddanmark、デンマーク、5000
- Odense Universitetshospital ( Site 0160)
-
-
-
-
-
Ankara、トルコ（Türkiye）、06230
- Hacettepe University Medical Faculty ( Site 0653)
-
Ankara、トルコ（Türkiye）、06800
- Ankara City Hospital-Medical Oncology ( Site 0661)
-
Edirne、トルコ（Türkiye）、22030
- Trakya University Medical Faculty Balkan Oncology Hospital ( Site 0648)
-
Istanbul、トルコ（Türkiye）、34093
- Bezmialem Vakf Üniversitesi-Oncology ( Site 0660)
-
Izmir、トルコ（Türkiye）、35100
- Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 0654)
-
Izmir、トルコ（Türkiye）、35575
- I.E.U. Medical Point Hastanesi ( Site 0649)
-
Konya、トルコ（Türkiye）、42080
- Konya Necmettin Erbakan University Medical Faculty ( Site 0652)
-
Malatya、トルコ（Türkiye）、44280
- Inonu Universitesi Medical Fakultesi ( Site 0650)
-
-
-
-
-
Berlin、ドイツ、13353
- Charite - Universitaetsmedizin ( Site 0204)
-
Hamburg、ドイツ、20246
- Universitaetsklinikum Hamburg-Eppendorf ( Site 0207)
-
-
Baden-Wurttemberg
-
Freiburg im Breisgau、Baden-Wurttemberg、ドイツ、79106
- Universitaetsklinikum Freiburg ( Site 0199)
-
-
Hesse
-
Frankfurt am Main、Hesse、ドイツ、60488
- Krankenhaus Nord-West GmbH ( Site 0208)
-
-
Lower Saxony
-
Hanover、Lower Saxony、ドイツ、30625
- Medizinische Hochschule Hannover ( Site 0200)
-
-
North Rhine-Westphalia
-
Bonn、North Rhine-Westphalia、ドイツ、53127
- Universitaetsklinikum Bonn ( Site 0203)
-
-
Saxony
-
Leipzig、Saxony、ドイツ、04103
- Universitaetsklinikum Leipzig ( Site 0202)
-
-
Saxony-Anhalt
-
Halle、Saxony-Anhalt、ドイツ、06120
- Universitaetsklinikum Halle ( Site 0213)
-
-
Schleswig-Holstein
-
Lübeck、Schleswig-Holstein、ドイツ、23538
- Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0215)
-
-
-
-
-
Auckland、ニュージーランド、1023
- Auckland City Hospital ( Site 0459)
-
-
-
-
-
Oslo、ノルウェー、0450
- Oslo Universitetssykehus Ullevål ( Site 0500)
-
-
-
-
-
Budapest、ハンガリー、1085
- Semmelweis University ( Site 0264)
-
-
Somogy County
-
Kaposvár、Somogy County、ハンガリー、7400
- Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 0267)
-
-
Zala County
-
Zalaegerszeg、Zala County、ハンガリー、8900
- Zala Megyei Szent Rafael Korhaz ( Site 0265)
-
-
-
-
Auvergne
-
Lyon、Auvergne、フランス、69004
- Hopital de la Croix-Rousse ( Site 0193)
-
-
Bouches-du-Rhone
-
Marseille、Bouches-du-Rhone、フランス、13005
- Hopital de la Timone ( Site 0188)
-
-
Gironde
-
Pessac、Gironde、フランス、33604
- CHU Bordeaux Haut-Leveque ( Site 0185)
-
-
Meurthe-et-Moselle
-
Vandœuvre-lès-Nancy、Meurthe-et-Moselle、フランス、54500
- C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 0180)
-
-
Val-de-Marne
-
Créteil、Val-de-Marne、フランス、94000
- A.P.H. Paris, Hopital Henri Mondor ( Site 0179)
-
Villejuif、Val-de-Marne、フランス、94800
- Hopital Paul Brousse ( Site 0182)
-
-
-
-
-
São Paulo、ブラジル、01509-900
- A.C. Camargo Cancer Center ( Site 0054)
-
-
Rio Grande do Norte
-
Natal、Rio Grande do Norte、ブラジル、59075-740
- Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0057)
-
-
Rio Grande do Sul
-
Porto Alegre、Rio Grande do Sul、ブラジル、91350-200
- Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0056)
-
-
Santa Catarina
-
Blumenau、Santa Catarina、ブラジル、89010-340
- Clinica de Oncologia Reichow ( Site 0052)
-
-
São Paulo
-
Barretos、São Paulo、ブラジル、14784-400
- Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 0058)
-
Jaú、São Paulo、ブラジル、17210-120
- Fundacao Dr Amaral Carvalho ( Site 0050)
-
São José do Rio Preto、São Paulo、ブラジル、15090-000
- Hospital de Base de Sao Jose de Rio Preto ( Site 0043)
-
São Paulo、São Paulo、ブラジル、01323-001
- BP - A Beneficencia Portuguesa de São Paulo ( Site 0046)
-
-
-
-
-
Hato Rey、プエルトリコ、00917
- Puerto Rico Medical Research Center LLC ( Site 0523)
-
Ponce、プエルトリコ、00717
- Ad-Vance Medical Research LLC ( Site 0527)
-
San Juan、プエルトリコ、00921-3201
- VA Caribbean Healthcare System ( Site 0524)
-
San Juan、プエルトリコ、00927
- FDI Clinical Research ( Site 0522)
-
-
-
-
-
Coimbra、ポルトガル、3000-075
- Centro Hospitalar e Universitario de Coimbra ( Site 0502)
-
Lisbon、ポルトガル、1169-050
- Unidade Local de Saude de São José - Hospital de Santo Antonio dos Capuchos ( Site 0505)
-
Porto、ポルトガル、4099-001
- Centro Hospitalar do Porto, E.P.E. - Hospital Geral de Sto. Antonio ( Site 0504)
-
Porto、ポルトガル、4200-072
- Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0503)
-
Porto、ポルトガル、4200-319
- Centro Hospitalar de Sao Joao. EPE - Hospital de Sao Joao ( Site 0501)
-
-
-
-
Anhui
-
Heifei、Anhui、中国、230001
- Anhui Provincial Hospital ( Site 0092)
-
-
Beijing Municipality
-
Beijing、Beijing Municipality、中国、100142
- Beijing Cancer Hospital ( Site 0099)
-
Beijing、Beijing Municipality、中国、100142
- Beijing Cancer Hospital ( Site 0105)
-
Beijing、Beijing Municipality、中国、100730
- Peking Union Medical College Hospital ( Site 0087)
-
-
Chongqing Municipality
-
Chongqing、Chongqing Municipality、中国、400042
- Chinese People s Liberation Army Army Characteristic Medical Center ( Site 0117)
-
Chongqing、Chongqing Municipality、中国、404000
- Chongqing University Three Gorges Hospital ( Site 0859)
-
-
Fujian
-
Fuzhou、Fujian、中国、350014
- Fujian Provincial Cancer Hospital ( Site 0085)
-
Fuzhou、Fujian、中国、350014
- The First Affiliated Hospital of Fujian Medical University ( Site 0089)
-
Fuzhou、Fujian、中国、350008
- Mengchao Hepatobiliary Hospital of Fujian Medical University ( Site 0121)
-
Xiamen、Fujian、中国、361015
- Zhongshan Hospital Fudan University (Xiamen Branch) ( Site 0133)
-
-
Guangdong
-
Guangzhou、Guangdong、中国、510000
- Zhujiang Hospital of Southern Medical University ( Site 0115)
-
Guangzhou、Guangdong、中国、510080
- Guangdong Provincial People s Hospital ( Site 0100)
-
Guangzhou、Guangdong、中国、510515
- NANFANG HOSPITAL SOUTHERN MEDICAL UNIVERSITY ( Site 0088)
-
Guangzhou、Guangdong、中国、510700
- SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 0128)
-
Zhuhai、Guangdong、中国、519000
- Jinan University - Zhuhai People's Hospital-Intervention Department ( Site 0856)
-
-
Guangxi
-
Nanning、Guangxi、中国、530021
- Guangxi Medical University Affiliated Tumor Hospital-Hepatological surgery ( Site 0862)
-
-
Hainan
-
Haikou、Hainan、中国、570311
- Hainan General Hospital ( Site 0112)
-
-
Heilongjiang
-
Harbin、Heilongjiang、中国、150081
- Harbin Medical University Cancer Hospital ( Site 0090)
-
-
Henan
-
Zhengzhou、Henan、中国、450008
- Henan Cancer Hospital ( Site 0114)
-
-
Hubei
-
Wuhan、Hubei、中国、430079
- Hubei Cancer Hospital ( Site 0101)
-
Wuhan、Hubei、中国、430000
- Tongji Hospital Tongji Medical,Science & Technology ( Site 0126)
-
-
Hunan
-
Changsha、Hunan、中国、410005
- Hunan Provincial People's Hospital ( Site 0113)
-
Changsha、Hunan、中国、410013
- Hunan Cancer Hospital ( Site 0096)
-
-
Jiangsu
-
Suzhou、Jiangsu、中国、215006
- The First Affiliated Hospital of Soochow University ( Site 0120)
-
-
Jiangxi
-
Nanchang、Jiangxi、中国、330029
- Jiangxi Provincial Cancer Hospital-Cancer Hospital ( Site 0134)
-
-
Shaanxi
-
Xi'an、Shaanxi、中国、710100
- Xi'an International Medical Center Hospital ( Site 0860)
-
-
Shanghai Municipality
-
Shanghai、Shanghai Municipality、中国、200028
- The Third Affiliated Hospital of the PLA Navy Medical University ( Site 0123)
-
Shanghai、Shanghai Municipality、中国、200032
- Fudan University Shanghai Cancer Center ( Site 0106)
-
Shanghai、Shanghai Municipality、中国、200032
- Zhongshan Hospital Fudan University ( Site 0084)
-
-
Shanxi
-
Xi’an、Shanxi、中国、710048
- The First Affiliated Hospital of Xi an Jiaotong University ( Site 0108)
-
-
Sichuan
-
Chengdu、Sichuan、中国、610041
- West China Hospital of Sichuan University ( Site 0119)
-
Suining、Sichuan、中国、629000
- Suining Central Hospital ( Site 0857)
-
-
Tianjin Municipality
-
Tianjin、Tianjin Municipality、中国、300060
- Tianjin Medical University Cancer Institute & Hospital ( Site 0098)
-
Tianjin、Tianjin Municipality、中国、300170
- Tianjin Third Central Hospital ( Site 0861)
-
-
Yunnan
-
Kunming、Yunnan、中国、650200
- The First Hospital of Kunming ( Site 0124)
-
-
Zhejiang
-
Hangzhou、Zhejiang、中国、310009
- 2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0110)
-
Hangzhou、Zhejiang、中国、310018
- Sir Run Run Shaw Hospital ( Site 0094)
-
Hangzhou、Zhejiang、中国、310022
- Zhejiang Cancer Hospital ( Site 0103)
-
Ningbo、Zhejiang、中国、315048
- Ningbo Medical Center LiHuili Hospital ( Site 0132)
-
-
-
-
-
Kaohsiung City、台湾、807
- Kaohsiung Medical University Hospital ( Site 0611)
-
Taichung、台湾、40447
- China Medical University Hospital-Surgical Department ( Site 0610)
-
Taichung、台湾、407
- Taichung Veterans General Hospital ( Site 0613)
-
Tainan、台湾、70457
- National Cheng Kung University Hospital ( Site 0608)
-
Taipei、台湾、10002
- National Taiwan University Hospital ( Site 0606)
-
Taipei、台湾、112201
- Taipei Veterans General Hospital-Division of Gastroenterology & Hepatology, Department of Medicine ( Site 0612)
-
Taoyuan、台湾、333
- Chang Gung Medical Foundation. Linkou ( Site 0607)
-
-
Kaohsiung
-
Kaohsiung City、Kaohsiung、台湾、833
- Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0609)
-
-
-
-
-
Chiba、日本、260-8677
- Chiba University Hospital ( Site 0346)
-
Fukuoka、日本、8108563
- National Hospital Organization Kyushu Medical Center ( Site 0361)
-
Hiroshima、日本、734-8551
- Hiroshima University Hospital ( Site 0360)
-
Kumamoto、日本、860-8556
- Kumamoto University Hospital ( Site 0372)
-
Kyoto、日本、602-8566
- University Hospital,Kyoto Prefectural University of Medicine ( Site 0367)
-
Osaka、日本、541-8567
- Osaka International Cancer Institute ( Site 0357)
-
Osaka、日本、543-8555
- Japanese Red Cross Osaka Hospital ( Site 0356)
-
Saga、日本、840-8571
- Saga-Ken Medical Centre Koseikan ( Site 0363)
-
Tokyo、日本、105-8470
- Toranomon Hospital ( Site 0349)
-
Tokyo、日本、113-0033
- Juntendo University Hospital ( Site 0371)
-
Tokyo、日本、113-8655
- The University of Tokyo Hospital ( Site 0348)
-
-
Chiba
-
Kashiwa、Chiba、日本、277-8577
- National Cancer Center Hospital East ( Site 0347)
-
-
Ehime
-
Tōon、Ehime、日本、791-0295
- Ehime University Hospital ( Site 0368)
-
-
Fukuoka
-
Kurume、Fukuoka、日本、830-0011
- Kurume University Hospital ( Site 0362)
-
-
Hokkaido
-
Sapporo、Hokkaido、日本、060-0033
- Sapporo Kosei General Hospital ( Site 0345)
-
-
Ishikawa-ken
-
Kanazawa、Ishikawa-ken、日本、920-8641
- Kanazawa University Hospital ( Site 0354)
-
-
Kagawa-ken
-
Takamatsu、Kagawa-ken、日本、760-8557
- Kagawa Prefectural Central Hospital ( Site 0364)
-
-
Kanagawa
-
Kawasaki、Kanagawa、日本、213-8587
- Toranomon Hospital Kajigaya ( Site 0369)
-
Yokohama、Kanagawa、日本、232-0024
- Yokohama City University Medical Center ( Site 0351)
-
Yokohama、Kanagawa、日本、241-8515
- Kanagawa Cancer Center ( Site 0352)
-
-
Nara
-
Kashihara、Nara、日本、634-8522
- Nara Medical University Hospital ( Site 0359)
-
-
Osaka
-
Sayama、Osaka、日本、589-8511
- Kindai University Hospital ( Site 0358)
-
-
Saitama
-
Iruma-gun、Saitama、日本、350-0495
- Saitama Medical University Hospital ( Site 0370)
-
-
Shizuoka
-
Suntogun、Shizuoka、日本、411-8777
- Shizuoka Cancer Center ( Site 0365)
-
-
Tochigi
-
Shimotsuke、Tochigi、日本、329-0498
- Jichi Medical University Hospital ( Site 0353)
-
-
-
-
-
Seoul、韓国、03080
- Seoul National University Hospital ( Site 0567)
-
Seoul、韓国、03722
- Severance Hospital Yonsei University Health System ( Site 0564)
-
Seoul、韓国、05505
- Asan Medical Center ( Site 0565)
-
Seoul、韓国、06351
- Samsung Medical Center ( Site 0566)
-
Seoul、韓国、06591
- The Catholic University of Korea St. Mary s Hospital ( Site 0571)
-
Seoul、韓国、08308
- Korea University Guro Hospital ( Site 0573)
-
-
Jeonranamdo
-
Hwasun、Jeonranamdo、韓国、58128
- Chonnam National University Hwasun Hospital ( Site 0572)
-
-
Kyonggi-do
-
Seongnam-si、Kyonggi-do、韓国、13620
- Seoul National University Bundang Hospital ( Site 0570)
-
-
Pusan-Kwangyokshi
-
Busan、Pusan-Kwangyokshi、韓国、49241
- Pusan National University Hospital ( Site 0568)
-
-
Taegu-Kwangyokshi
-
Daegu、Taegu-Kwangyokshi、韓国、41944
- Kyungpook National University Hospital ( Site 0569)
-
-
-
-
-
Shatin、香港
- Prince of Wales Hospital ( Site 0242)
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
説明
包含基準:
- -放射線学、組織学、または細胞学によってHCCの診断が確認されている
- HCC が肝臓に限局しており、根治的治療を受けられない
- C型肝炎ウイルス（HCV）の参加者は、治療が開始の少なくとも1か月前に完了した場合に適格です 研究介入
- B型肝炎ウイルス（HBV）の参加者は資格があります
- 降圧薬の有無にかかわらず、血圧が適切に管理されている
- 十分な臓器機能を持っている
除外基準:
- 現在、肝移植の候補です
- 過去6か月以内に胃出血があった
- 薬でコントロールできない腹水がある
- -うっ血性心不全などの研究介入の最初の投与から12か月以内に重大な心血管障害がある
- 治癒しない深刻な傷、潰瘍、または骨折がある
- -既存の肝病変に対して局所領域療法を受けている
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：レンバチニブ + ペムブロリズマブ + TACE
参加者は、レンバチニブ、ペムブロリズマブ、および TACE の組み合わせを受け取ります。
レンバチニブは、12mg（スクリーニング体重が60kg以上の参加者の場合）または8mg（スクリーニング体重の参加者の場合）の用量で投与されます
|
12 mg（スクリーニング体重≥60 kgの参加者の場合）または8 mg（スクリーニング体重の参加者の場合）の用量で投与
他の名前：
6 週間に 1 回 (Q6W)、400 mg の用量で IV 注入を介して投与されます。
他の名前：
化学療法剤および塞栓剤のバックグラウンド手順として実施。
|
|
アクティブコンパレータ：経口 プラセボ + IV プラセボ + TACE
参加者は、レンバチニブと一致する経口プラセボ、ペムブロリズマブと一致する IV プラセボ、および TACE の組み合わせを受け取ります。
レンバチニブと一致する経口プラセボは、治験依頼者の承認を得て、各 21 日サイクルで 1 日 1 回、最大 2 年間 (約 35 サイクル) またはそれ以上投与されます。 2年（〜17回）。
参加者は、化学療法および塞栓剤のバックグラウンド手順としてTACEを受けます。
|
化学療法剤および塞栓剤のバックグラウンド手順として実施。
レンバチニブと一致するプラセボを、21 日周期ごとに 1 日 1 回、経口カプセルで投与します。
ペムブロリズマブと一致するプラセボを 6 週間に 1 回 (Q6W) 静注で投与。
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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)
時間枠：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)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
PFS Per Modified RECIST (mRECIST) as Assessed by BICR
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
協力者
捜査官
- スタディディレクター：Medical Director、Merck Sharp & Dohme LLC
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2020年5月22日
一次修了 (実際)
2025年8月19日
研究の完了 (実際)
2026年3月26日
試験登録日
最初に提出
2020年1月27日
QC基準を満たした最初の提出物
2020年1月27日
最初の投稿 (実際)
2020年1月29日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月3日
QC基準を満たした最後の更新が送信されました
2026年9月1日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 7902-012
- 2019 (米国 NIH グラント/契約：Chief Medical Office (CMO) Alberta Health Services)
- MK-7902-012 (その他の識別子：MSD Protocol Number)
- LEAP-012 (その他の識別子：MSD)
- E7080-G000-318 (その他の識別子：Eisai Protocol Number)
- 205286 (レジストリ識別子：JAPIC-CTI)
- 2019-002345-37 (EudraCT番号)
- 2022-502116-36-00 (レジストリ識別子：EU CT)
- U1111-1283-3439 (レジストリ識別子：UTN)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。