TORIPALIMAB INJECTION(JS001 ): Arm A: Toripalimab 240mg IV(Injection of Vein) Q3W Arm B: Placebo 240mg IV(Injection of Vein) Q3W
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
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/exclusion criteria could apply
Primary outcome measure(s)
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.
Trial sites (1)
Facility
City
Region
Status
Zhongshan Hospital,Fudan University
Shanghai
Shanghai Municipality
More Shanghai Junshi Bioscience Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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