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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II/III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Toripalimab (Recombinant Humanized Anti-PD-1 Monoclonal Antibody, JS001) Versus Placebo as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence Following Radical Resection

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Biological: TORIPALIMAB INJECTION(JS001 )


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HCC with at least one protocol defined risk factor, diagnosed confirmed by central pathological review and received R0 resection; BICR confirmed no resdual tumor lesions are detected in liver; Child-Puch score, Class A; ECOG score is 0; Exclusion Criteria: 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; Portal vein tumor thrombi or liver metastases or recurrent liver cancer; With symptoms of central nervous system metastasis; With any history of active autoimmune disease or autoimmune disease; Known liver diseases with clinical significance; Patients infected by hepatitis B virus (HBV), hepatitis C virus (HCV), hepatitis D virus (HDV): Other protocol defined inclusion/exclusion criteria could apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>TORIPALIMAB 240mg ,Q3W, up to 16 cycles | Biological: TORIPALIMAB INJECTION(JS001 )<br>* Arm A: Toripalimab 240mg IV(Injection of Vein) Q3W Arm B: Placebo 240mg IV(Injection of Vein) Q3W<br>|
| Placebo Comparator: Group B<br>Placebo 240mg Q3W, up to 16 cycles | Biological: TORIPALIMAB INJECTION(JS001 )<br>* Arm A: Toripalimab 240mg IV(Injection of Vein) Q3W Arm B: Placebo 240mg IV(Injection of Vein) Q3W<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BICR-RFS | Defined as the time from randomization to the first documented disease recurrence or death. | Time frame is up to 31 months (for interim analysis, up to 44 months for Primary analysis) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | up to 44 months | 
| 12-month recurrence-free survival rate (RFS12) | probability of patients without recurrence or death for any cause at Month 12 | up to 44 months | 
| 24-month recurrence-free survival rate (RFS24) | probability of patients without recurrence or death for any cause at Month 24 | up to 44 months | 
| Time to recurrence (TTR) | the time from randomization to the first documented disease recurrence | up to 44 months | 
| Time to local recurrence (TTLR) | the time from randomization to the first documented local disease recurrence | up to 44 months | 
| Overall survival (OS) | the time from randomization to death for any cause | up to 44 months | 
| 12- and 24-month overall survival rate (OS12 and OS24) | probability of patients surviving at Month 12 and 24, respectively | up to 44 months | 
| Incidence of AEs | Incidence of AEs (including SAEs and AESIs) is evaluated by the investigator, and severity is determined in accordance with CTCAE v5.0 | up to 44 months |