Phase III Study of Toripalimab（JS001） Combined With Lenvatinib for Advanced HCC
- Conditions
- Advanced Hepatocellular Carcinoma (HCC)
- Interventions
- Combination Product: Placebo combined with LenvatinibCombination Product: Toripalimab combined with Lenvatinib
- Registration Number
- NCT04523493
- Lead Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- 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
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 530
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Control group Placebo combined with Lenvatinib Placebo combined with Lenvatinib Experimental group Toripalimab combined with Lenvatinib Toripalimab combined with Lenvatinib
- Primary Outcome Measures
Name Time Method Overall survival (OS) Up to 3 years The time from randomization to death for any reason.
- Secondary Outcome Measures
Name Time Method PFS rate Up to 3 years The PFS rate on 6 months and 1year in both groups.
Progression-free survival (PFS) Up to 3 years The time from randomization to progression of disease or death for any reason, whichever comes first. Progression of disease will be evaluated
PK To be collected once within 60 minutes prior to administration each for Toripalimab/placebo on Day 1 of Cycle (each cycle is 21 days). but the no-china sites not collection the sample According to the test of blood samples, the pharmacokinetic parameters of Toripalimab, mainly trough concentration, will be analyzed.
Immunogenicity Up to 3 years Plasma level of anti-Toripalimab injection (JS001) antibody, immunoglobulin and Toripalimab injection (JS001) will be summarized descriptively.
TTP Up to 3 years Defined as the time from randomization to objective tumor progression.
OS rate Up to 3 years The OS rate on 1year and 2years in both groups.
ORR Up to 3 years Defined as the proportion of subjects with the best overall response of complete response (CR) or partial response (PR).
Duration of Response (DOR) Up to 3 years Defined as the time from the first evaluation of CR or PR to the first evaluation of PD or death for any reason.
DCR Up to 3 years Defined as the proportion of subjects with the best overall response (BOR) of CR, PR or SD.
Incidence,severity and prognosis of AEs/SAEs as assessed by NCI-CTCAE v5.0 From date of consent informed until 90 days after the last investigational product administration. Up to 2 approximately years. Verbatim descriptions of adverse events will correspond to MedDRA synonymous terms, and AEs will be graded in accordance with NCI-CTCAE version 5.0. All the adverse events during or after the first dose of study drug will be summarized by treatment groups and NCI CTCAE grade. In addition, serious adverse events, adverse events (grade 3 or above) and the adverse events leading to discontinuation or suspension of study drug will be summarized correspondingly. Multiple occurrence of the same event will be counted once in accordance with the highest severity. The proportion of subjects with at least one adverse event will be reported by term of toxicity and treatment groups.
Trial Locations
- Locations (23)
Copernicus Podmiot Leczniczy sp. z o.o., Wojewodzkie Centrum Onkologii, Oddzial Onkologii Klinicznej/Chemioterapii
🇵🇱Gdansk, Poland
PRATIA MCM Kraków, ul. Pana Tadeusza 2,
🇵🇱Krakow, Poland
Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie, Oddzial Dzienny Chemioterapii
🇵🇱Koszalin, Poland
ID Clinic
🇵🇱Mysłowice, Poland
Wielkopolskie Centrum Onkologii, Oddział Onkologii Klinicznej i Immunoonkologii z Pododdziałem Dziennym i Izbą Przyjęć
🇵🇱Poznan, Poland
National Cancer Centre Singapore
🇸🇬Singapore, Singapore
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy, Klinika Onkologii i Radioterapii
🇵🇱Warszawa, Poland
Qinhuai Medical Area, General Hospital of PLA Eastern Theater Command
🇨🇳Nanjing, Jiangsu, China
A.O.U. Citta della Salute e della Scienza di Torino
🇮🇹Tortona, Italy
Azienda Ospedaliera Universitaria Careggi
🇮🇹Firenze, Italy
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico,Oncologia Medica
🇮🇹Milan, Italy
Azienda Ospedaliero Universitaria Pisana
🇮🇹Pisa, Italy
AOUI Verona - Policlinico "G.B. Rossi" di Borgo Roma
🇮🇹Verona, Italy
Communal Non-commercial Enterprise City Clinical Hospital #4 of Dnipro City Council, Department of Chemotherapy
🇺🇦Dnipro, 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. scientific certer 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 Zaporizhzhia Regional Antitumor Center of Zaporizhzhia Regional Council
🇺🇦Zaporizhzhia, Ukraine
Communal Non-commercial Enterprise of Sumy Regional Council, Sumy Regional Clinical Oncological Dispensar
🇺🇦Sumy, Ukraine
IRCCS Fondazione Giovanni Pascale, Istituto Nazionale Dei Tumori
🇮🇹Napoli, Italy
Centrum Medyczne Pratia Poznań
🇵🇱Skórzewo, Poland
Communal Non-profit Enterprise "Regional Center of Oncology", Department of Abdominal Organs Oncosurgery
🇺🇦Kharkiv, Ukraine