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
Overview
- Phase
- Phase 3
- Intervention
- Sintilimab
- Conditions
- HCC
- Sponsor
- Sun Yat-sen University
- Enrollment
- 246
- Locations
- 1
- Primary Endpoint
- Recurrence-free Survival (RFS)
- Status
- Not yet recruiting
- Last Updated
- 5 years ago
Overview
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) patients who are at high risk of recurrence after radical resection
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 recurrence after radical resection.
Investigators
Chen Min-Shan
MD, Department of Hepatobilliary Surgery
Sun Yat-sen University
Eligibility Criteria
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
Arms & Interventions
Arm A
sintilimab 200mg + bevacizumab 7.5mg/kg IV Q3W
Intervention: Sintilimab
Arm A
sintilimab 200mg + bevacizumab 7.5mg/kg IV Q3W
Intervention: Bevacizumab
Outcomes
Primary Outcomes
Recurrence-free Survival (RFS)
Time Frame: up to 36 months after randomization
RFS is defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC as determined by the investigator, or death due to any cause (whichever occurs first).
Secondary Outcomes
- Adverse Events (AEs)(up to 48 months after randomization)
- OS Rate at 24 and 36 Months(at 24 and 36 months after randomization)
- Overall Survival (OS）(up to 48 months after randomization)
- RFS Rate at 12 and 24 months(at 12 and 24 months after randomization)
- TTR(time to recurrence)(up to 36 months after randomization)