Last updated: December 20, 2020
Sponsor: Sun Yat-sen University
Overall Status: Active - Not Recruiting
Phase
3
Condition
Chemotherapy
Cancer Treatment
Vaccines
Treatment
N/AClinical Study ID
NCT04682210
B2020-280-01
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients with a first diagnosis of HCC who have undergone a curative resection
- Radiologic evidence of disease free ≥4 weeks after complete surgical resection
- Full recovery from surgical resection or post-operative transarterialchemoembolization before randomization
- Randomization needs to occur within 12 weeks of the date of surgical resection
- High risk for HCC recurrence as protocol defined
- Child-Pugh Score, Class A
- ECOG performance status 0 or 1
- No prior systemic anticancer therapy for HCC
- Adequate hematologic and organ function
Exclusion
Exclusion Criteria:
- Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
- Evidence of residual, recurrent, or metastatic disease at randomization
- History of hepatic encephalopathy or organ transplantation
- Patients who are in the waiting list for liver transplantation
- Patients with Vp4 portal vein thrombosis
- Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or otherimmunotherapy
- Pregnant or lactating women
Study Design
Total Participants: 246
Study Start date:
December 01, 2020
Estimated Completion Date:
December 31, 2024
Study Description
Connect with a study center
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong 510060
ChinaSite Not Available

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