A Phase 3, Randomized, Open-Label, Active-Controlled, Multicenter Study of ZG005 in Combination With Bevacizumab Versus Sintilimab in Combination With Bevacizumab in the First-Line Treatment of Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
The purpose of the study is to evaluate the efficacy of ZG005 combined with bevacizumab compared with sintilimab combined with bevacizumab in the first-line treatment of participants with advanced HCC
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
- •Participants with histologically/cytologically confirmed unresectable or metastatic advanced HCC;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
- •Barcelona Clinic Liver Cancer stage B, not suitable for local treatment and BCLC C.
- •At least one measurable lesion based on Recist1.
- •No prior systemic therapy for HCC.
- •Child-Pugh ≤6 , no history of hepatic encephalopathy.
排除标准
- •Active Central nervous system (CNS) metastasis or leptomeningeal metastases.
- •Any condition that is not suitable for participate in this study as determined by investigator.
研究组 & 干预措施
ZG005+Bevacizumab
ZG005 20 mg/kg administered intravenously every 3 weeks (Q3W) + Bevacizumab(Avastin) 15 mg/kg administered intravenously Q3W
干预措施: ZG005 for Injection (Drug)
Sintilimab Plus Bevacizumab
Sintilimab 200 mg administered intravenously Q3W + Bevacizumab (达攸同) 15 mg/kg administered intravenouslyQ3W
干预措施: Sintilimab (Drug)
ZG005+Bevacizumab
ZG005 20 mg/kg administered intravenously every 3 weeks (Q3W) + Bevacizumab(Avastin) 15 mg/kg administered intravenously Q3W
干预措施: Bevacizumab ( Avastin) (Drug)
Sintilimab Plus Bevacizumab
Sintilimab 200 mg administered intravenously Q3W + Bevacizumab (达攸同) 15 mg/kg administered intravenouslyQ3W
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: up to 3 years
PFS evaluated by the Blinded Independent Review Committee (IRC) based on RECIST V1.1
Overall survival (OS)
时间窗: up to 5 years
次要结局
- PFS(up to 3 years)
- Objective response rate (ORR)(up to 3 years)