Toripalimab or Placebo as Adjuvant Therapy in Hepatocellular Carcinoma After Radical Resection

Shanghai Junshi Bioscience Co., Ltd.402 enrolled

Overview

This study will investigate if Toripalimab (A PD-1 Inhibitor) will improve recurrence-free survival (RFS) compared to placebo in participants with HCC and are at high risk of recurrence after complete resection with no residual of tumour.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

402

Conditions

Hepatocellular Carcinoma

Interventions

TORIPALIMAB INJECTION(JS001 )BIOLOGICAL

Arm A: Toripalimab 240mg IV(Injection of Vein) Q3W Arm B: Placebo 240mg IV(Injection of Vein) Q3W

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. HCC with at least one protocol defined risk factor, diagnosed confirmed by central pathological review and received R0 resection; 2. BICR confirmed no resdual tumor lesions are detected in liver; 3. Child-Puch score, Class A; 4. ECOG score is 0; Exclusion Criteria: 1. Patients previously received PD-1 antibody, PD-L1 antibody, PD-L2 antibody or CTLA-4 antibodies, including those who have participated in the JS001 clinical study; 2. Portal vein tumor thrombi or liver metastases or recurrent liver cancer; 3. With symptoms of central nervous system metastasis; 4. With any history of active autoimmune disease or autoimmune disease; 5. Known liver diseases with clinical significance; 6. Patients infected by hepatitis B virus (HBV), hepatitis C virus (HCV), hepatitis D virus (HDV): Other protocol defined inclusion/exclusion criteria could apply

Locations (1)

Zhongshan Hospital,Fudan University

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

BICR-RFS

Defined as the time from randomization to the first documented disease recurrence or death.

Time frame: Time frame is up to 31 months (for interim analysis, up to 44 months for Primary analysis)

Secondary Outcomes

Investigator-RFS

the time from randomization to the date of the first documented progressive disease (tumor evlauation by BICR in accordance with RECIST 1.1), or to the date of death for any cause, whichever occurs first

Time frame: up to 44 months

12-month recurrence-free survival rate (RFS12)

probability of patients without recurrence or death for any cause at Month 12

Time frame: up to 44 months

24-month recurrence-free survival rate (RFS24)

probability of patients without recurrence or death for any cause at Month 24

Time frame: up to 44 months

Time to recurrence (TTR)

the time from randomization to the first documented disease recurrence

Time frame: up to 44 months

Time to local recurrence (TTLR)

the time from randomization to the first documented local disease recurrence

Time frame: up to 44 months

Overall survival (OS)

the time from randomization to death for any cause

Time frame: up to 44 months

12- and 24-month overall survival rate (OS12 and OS24)

Data from ClinicalTrials.gov

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