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
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 246
- 试验地点
- 1
- 主要终点
- Recurrence-free Survival (RFS)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm A
sintilimab 200mg + bevacizumab 7.5mg/kg IV Q3W
干预措施: Sintilimab (Drug)
Arm A
sintilimab 200mg + bevacizumab 7.5mg/kg IV Q3W
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Recurrence-free Survival (RFS)
时间窗: 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).
次要结局
- 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)
研究者
Chen Min-Shan
MD, Department of Hepatobilliary Surgery
Sun Yat-sen University