Hepatocellular Carcinoma
Conditions
Brief summary
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.
Interventions
BIOLOGICALTORIPALIMAB INJECTION(JS001 )
Arm A: Toripalimab 240mg IV(Injection of Vein) Q3W Arm B: Placebo 240mg IV(Injection of Vein) Q3W
Sponsors
Shanghai Junshi Bioscience Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BICR-RFS | Time frame is up to 100 months (for interim analysis, up to 92 months for Primary analysis) | Defined as the time from randomization to the first documented disease recurrence or death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator-RFS | up to 100 months | 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 |
| 12-month recurrence-free survival rate (RFS12) | up to 100 months | probability of patients without recurrence or death for any cause at Month 12 |
| 24-month recurrence-free survival rate (RFS24) | up to 100 months | probability of patients without recurrence or death for any cause at Month 24 |
| Time to recurrence (TTR) | up to 44 months | the time from randomization to the first documented disease recurrence |
| Time to local recurrence (TTLR) | up to 44 months | the time from randomization to the first documented local disease recurrence |
| Overall survival (OS) | up to 44 months | the time from randomization to death for any cause |
| 12- and 24-month overall survival rate (OS12 and OS24) | up to 44 months | probability of patients surviving at Month 12 and 24, respectively |
| Incidence of AEs | up to 44 months | Incidence of AEs (including SAEs and AESIs) is evaluated by the investigator, and severity is determined in accordance with CTCAE v5.0 |
Countries
China
Outcome results
None listed