NCT04720716已完成3 期
A Randomized, Open-label, Controlled, Multicenter Phase III Clinical Study to Compare the Effectiveness and Safety of IBI310 Combined With Sintilimab Versus Sorafenib in the First-line Treatment of Advanced Hepatocellular Carcinoma
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 344
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
This is a randomized, open-label, controlled, multicenter Phase III study to evaluate the effectiveness and safety of IBI310 combined with sintilimab and sorafenib in patients with locally advanced or metastatic HCC who have not previously received systemic therapy, are unsuitable for radical surgical resection or local treatment, or have had progressive disease after surgical resection or local treatment.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically/cytologically confirmed hepatocellular carcinoma, or liver cirrhosis meeting the clinical diagnostic criteria;
- •ECOG performance status score of 0 or 1 point;
- •No systemic antitumor treatment for hepatocellular carcinoma before the first administration;
- •Barcelona Clinic Liver Cancer stage C, or Stage B not suitable for radical surgery and/or local treatment;
- •At least 1 measurable lesion according to RECIST V1.1);
- •Child-Pugh:≤6
- •Adequate organ and bone marrow function.
排除标准
- •With fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues.
- •Have a history of hepatic encephalopathy or have a history of liver transplantation.
- •With clinical symptoms requires drainage of pleural effusion, ascites or pericardial effusion.
- •Central nervous system (CNS) metastasis.
- •Uncontrolled high blood pressure, systolic blood pressure >140mmHg or diastolic blood pressure >90mmHg after optimal medical treatment.
- •Local treatment for liver lesions within 4 weeks.
研究组 & 干预措施
Sintilimab combined with IBI310
Experimental
干预措施: IBI310 (Drug)
Sintilimab combined with IBI310
Experimental
干预措施: Sintilimab (Drug)
Sorafenib
Active Comparator
干预措施: Sorafenib (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: up to 24 months after randomization
Objective response rate (ORR)
时间窗: up to 24 months after randomization
Objective response rate (ORR) in two arms based on RECIST V1.1 by the IRRC
次要结局
- Duration of response(DOR)(up to 24 months after randomization)
- Disease control rate(DCR)(up to 24 months after randomization)
- Time to response(TTR)(up to 24 months after randomization)
- The incidence and severity of Treatment-Emergent Adverse Events(up to 24 months after randomization)
- Time to progression(TTP)(up to 24 months after randomization)
- Progression-free survival (PFS)(up to 24 months after randomization)
研究者
研究点 (1)
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