A Study to Evaluate the Efficacy and Safety of the Sintilimab Combined With Bevacizumab and Liver Protective Support Therapy in Child-Pugh B and/or ECOG PS 2 Unresectable Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Adverse Events (AEs)
研究概览
简要总结
To evaluate the efficacy and safety of sintilimab combined with bevacizumab and liver protective support therapy in Child-Pugh B and/or ECOG PS 2 unresectable hepatocellular carcinoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced unresectable hepatocellular carcinoma confirmed by histology or cytology
- •Age 20-79
- •At least one measurable lesion defined in RECIST version 1.1
- •Child Pugh grade B
- •ECOG PS score 2
- •The expected life is at least 90 days
排除标准
- •Previously received anti-PD-1, PD-L1, PD-L2, CD137, CTLA-4 antibody treatment, or any other treatment that regulates T cells
- •Received systemic corticosteroid or immunosuppressive therapy within 28 days before enrollment
- •Complicated with autoimmune diseases or having a history of chronic or recurrent autoimmune diseases
- •History of pleural or pericardial adhesions within 28 days before enrollment
- •HIV antibody, HTV-Ⅰantibody, HCV antibody, hepatitis B surface protein antigen, hepatitis B surface protein antibody, hepatitis B core protein antibody or any detectable hepatitis B virus DNA test results were positive
- •Multiple primary cancers (excluding completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer, and any other cancer that has not recurred for at least 5 years)
- •Brain or meningeal metastasis (unless asymptomatic and does not require treatment)
- •Uncontrollable or serious cardiovascular disease.
研究组 & 干预措施
experimental group
Sintilimab Combined With Bevacizumab and Liver Protective Support Therapy
干预措施: Sintilimab (Drug)
experimental group
Sintilimab Combined With Bevacizumab and Liver Protective Support Therapy
干预措施: Bevacizumab (Drug)
experimental group
Sintilimab Combined With Bevacizumab and Liver Protective Support Therapy
干预措施: Liver Protective Support Therapy (Combination Product)
结局指标
主要结局
Adverse Events (AEs)
时间窗: Up to 3 years
Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0
Overall survival (OS)
时间窗: Up to 3 years
Defined as the time from the date of treatment start to the date of death
次要结局
- Overall response rate (ORR)(Up to 1 years)
- Disease control rate (DCR)(Up to 1 years)
- Quality of Life (QoL)(Up to 3 years)