Sintilimab Plus Bevacizumab as Adjuvant Therapy in HCC Patients at High Risk of Recurrence After Curative Resection

A Phase III, Randomized, Open-lable, Multi Center Study of Sintilimab Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Curative Hepatic Resection

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) patients who are at high risk of recurrence after radical resection

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 recurrence after radical resection.

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 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 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 other immunotherapy
• Pregnant or lactating women