Phase III Study of Toripalimab(JS001) Combined With Lenvatinib for Advanced HCC

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

530

Participants

Timeline

Start Date

June 29, 2020

Primary Completion Date

December 31, 2025

Study Completion Date

September 1, 2026

Conditions
Advanced Hepatocellular Carcinoma (HCC)
Interventions
COMBINATION_PRODUCT

Toripalimab combined with Lenvatinib

"Experimental group:~Toripalimab, 240mg, IV infusion, every 3 weeks (q3w). combined with Lenvatinib 12 mg/day (Body Weight≥60 kg) or 8 mg/day (Body Weight\<60 kg) oral administration, once daily. Continuous infusion, in a cycle of 3 weeks (21 days), until occurrence of termination event specified in the protocol."

COMBINATION_PRODUCT

Placebo combined with Lenvatinib

"Control group:~Placebo, one unit, IV infusion, once every 3 weeks, combined with Lenvatinib 12 mg/day (Body Weight≥60 kg) or 8 mg/day (Body Weight\<60 kg) oral administration, once daily. Continuous infusion, in a cycle of 3 weeks (21 days), until occurrence of termination event specified in the protocol."

Trial Locations (23)

20122

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico,Oncologia Medica, Milan

21000

Qinhuai Medical Area, General Hospital of PLA Eastern Theater Command, Nanjing

37134

"AOUI Verona - Policlinico G.B. Rossi di Borgo Roma", Verona

40022

Communal Non-commercial Enterprise of Sumy Regional Council, Sumy Regional Clinical Oncological Dispensar, Sumy

43018

Communal Enterprise Volyn Regional Clinical Hospital of Volyn Regional Council, Lutsk

49102

Communal Non-commercial Enterprise City Clinical Hospital #4 of Dnipro City Council, Department of Chemotherapy, Dnipro

50134

Azienda Ospedaliera Universitaria Careggi, Florence

56126

Azienda Ospedaliero Universitaria Pisana, Pisa

61070

"Communal Non-profit Enterprise Regional Center of Oncology, Department of Abdominal Organs Oncosurgery", Kharkiv

61166

Communal Non-Profit Institution of Kharkiv Regional Council Regional Clinical Specialized Dispensary of Radiation Protection of Population, Kharkiv

65025

Communal Non-commercial Enterprise Odesa Regional Clinical Hospital of Odesa Regional Council, Department of General Surgery, Odesa

69040

Communal Non-commercial Enterprise Zaporizhzhia Regional Antitumor Center of Zaporizhzhia Regional Council, Zaporizhzhia

80131

IRCCS Fondazione Giovanni Pascale, Istituto Nazionale Dei Tumori, Napoli

168583

National Cancer Centre Singapore, Singapore

Unknown

A.O.U. Citta della Salute e della Scienza di Torino, Tortona

80-219

Copernicus Podmiot Leczniczy sp. z o.o., Wojewodzkie Centrum Onkologii, Oddzial Onkologii Klinicznej/Chemioterapii, Gdansk

75-581

Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie, Oddzial Dzienny Chemioterapii, Koszalin

30-727

PRATIA MCM Kraków, ul. Pana Tadeusza 2,, Krakow

41-400

ID Clinic, Mysłowice

61-866

Wielkopolskie Centrum Onkologii, Oddział Onkologii Klinicznej i Immunoonkologii z Pododdziałem Dziennym i Izbą Przyjęć, Poznan

60-185

Centrum Medyczne Pratia Poznań, Skórzewo

02-034

Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy, Klinika Onkologii i Radioterapii, Warsaw

03126

State Inst. O.O.Shalimov Nat. scientific certer of Surgery and Transplantology of Nat. Academy of Med.Sciences of Ukraine, Dep.of Oncology, Kyiv

All Listed Sponsors
lead

Shanghai Junshi Bioscience Co., Ltd.

OTHER