Spots Global Cancer Trial Database for Phase III Study of Toripalimab（JS001） Combined With Lenvatinib for Advanced HCC
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Trial Identification
Brief Title: Phase III Study of Toripalimab（JS001） Combined With Lenvatinib for Advanced HCC
Official Title: A Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter Phase III Study to Compare Toripalimab Combined With Lenvatinib Versus Placebo Combined With Lenvatinib as the 1st-line Therapy for Advanced HCC
Study ID: NCT04523493
Conditions
Study Description
Brief Summary: This is a prospective, randomized, placebo-controlled, double-blind, multicenter phase III registration clinical study to observe, compare and evaluate the efficacy and safety of Toripalimab combined with Lenvatinib versus placebo combined with Lenvatinib as the 1st-line therapy for advanced HCC. Eligible subjects will be randomized at a ratio of 2:1 to receive Toripalimab combined with Lenvatinib (experimental group) or Placebo combined with Lenvatinib (control group).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Alliance for Multispecialty Research, LLC, Kansas City, Missouri, United States
Qinhuai Medical Area, General Hospital of PLA Eastern Theater Command, Nanjing, Jiangsu, China
Azienda Ospedaliera Universitaria Careggi, Firenze, , Italy
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico,Oncologia Medica, Milan, , Italy
IRCCS Fondazione Giovanni Pascale, Istituto Nazionale Dei Tumori, Napoli, , Italy
Azienda Ospedaliero Universitaria Pisana, Pisa, , Italy
A.O.U. Citta della Salute e della Scienza di Torino, Tortona, , Italy
AOUI Verona - Policlinico "G.B. Rossi" di Borgo Roma, Verona, , Italy
Copernicus Podmiot Leczniczy sp. z o.o., Wojewodzkie Centrum Onkologii, Oddzial Onkologii Klinicznej/Chemioterapii, Gdansk, , Poland
Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie, Oddzial Dzienny Chemioterapii, Koszalin, , Poland
PRATIA MCM Kraków, ul. Pana Tadeusza 2,, Krakow, , Poland
ID Clinic, Mysłowice, , Poland
Wielkopolskie Centrum Onkologii, Oddział Onkologii Klinicznej i Immunoonkologii z Pododdziałem Dziennym i Izbą Przyjęć, Poznan, , Poland
Centrum Medyczne Pratia Poznań, Skórzewo, , Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy, Klinika Onkologii i Radioterapii, Warszawa, , Poland
National Cancer Centre Singapore, Singapore, , Singapore
Communal Non-commercial Enterprise City Clinical Hospital #4 of Dnipro City Council, Department of Chemotherapy, Dnipro, , Ukraine
Communal Non-profit Enterprise "Regional Center of Oncology", Department of Abdominal Organs Oncosurgery, Kharkiv, , Ukraine
Communal Non-Profit Institution of Kharkiv Regional Council Regional Clinical Specialized Dispensary of Radiation Protection of Population, Kharkiv, , Ukraine
State Inst.O.O.Shalimov Nat.Institute of Surgery and Transplantology of Nat.Academy of Med.Sciences of Ukraine, Dep.of Oncology, Kyiv, , Ukraine
Communal Enterprise Volyn Regional Clinical Hospital of Volyn Regional Council, Luts'k, , Ukraine
Communal Non-commercial Enterprise Odesa Regional Clinical Hospital of Odesa Regional Council, Department of General Surgery, Odesa, , Ukraine
Communal Non-commercial Enterprise of Sumy Regional Council, Sumy Regional Clinical Oncological Dispensar, Sumy, , Ukraine
Communal Non-commercial Enterprise Zaporizhzhia Regional Antitumor Center of Zaporizhzhia Regional Council, Zaporizhzhia, , Ukraine
Contact Details
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