Status:
UNKNOWN
Sintilimab Plus Bevacizumab as Adjuvant Therapy in HCC Patients at High Risk of Recurrence After Curative Resection
Lead Sponsor:
Sun Yat-sen University
Conditions:
HCC
Adjuvant Therapy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is an open label, multi-center, randomized, controlled phase III study, to evaluate the efficacy and safety of sintilimab plus bevacizumab as adjuvant therapy in hepatocellular carcinoma (HCC) pa...
Detailed Description
There is no stardard adjuvant treatment for HCC. This study is to to evaluate the efficacy and safety of sintilimab plus bevacizumab as adjuvant therapy in HCC patients who are at high risk of recurre...
Eligibility Criteria
Inclusion
- 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 transarterial chemoembolization 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
- 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 other immunotherapy
- Pregnant or lactating women
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT04682210
Start Date
December 1 2020
End Date
December 1 2024
Last Update
December 23 2020
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060