Status:
UNKNOWN
Toripalimab or Placebo as Adjuvant Therapy in Hepatocellular Carcinoma After Radical Resection
Lead Sponsor:
Shanghai Junshi Bioscience Co., Ltd.
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT03859128
Start Date
March 5 2019
End Date
August 1 2023
Last Update
March 31 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Zhongshan Hospital,Fudan University
Shanghai, Shanghai Municipality, China, 200032