NCT02645981已完成2 期
Efficacy and Safety of Donafenib in Patients With Advanced Hepatocellular Carcinoma: a Controlled,Multicentre,Randomised, Phase 3 Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 668
- 试验地点
- 2
- 主要终点
- Overall Survival
研究概览
简要总结
Donafenib versus sorafenib for advanced hepatocellular cancer.
详细描述
This phase 3 study of donafenib, an oral multikinase inhibitor that targets Raf kinase and receptor tyrosine kinases, is to assess efficacy and safety in patients wiht advanced hepatocellular carcinoma (HCC).The study is a randomised,controlled,multicentre study.The controlled drug is sorafenib(Nexavar).The primary endpoint is overall survival.
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
盲法说明
open-label
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
- •Above 18 years old;
- •Patients with measurable, histologically or clinical proven, inoperable HCC;
- •Patients wtih measurable lesion and proved by independent radiology committee(IRC);
- •Child-Pugh (CP) score of 7 or less；
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less;
- •Patients had not received prior systemic treatments for HCC;
- •Life expectancy at least 3 months;
- •Adequate hepatic and renal function;
- •Adequate hematologic function (platelet count,≥75×109per liter;hemoglobin ≥9.0g per deciliter;neutrophil≥1.5×109per liter,);
- •Prothrombin time international normal.
排除标准
- •Patients received operate in 3 months;
- •Patients received transcatheter arterial chemoembolization（TACE） in 4 weeks;
- •Patients had received systemic therapy;
- •Patients had prior treatment with sorafenib;
- •Central nervous system(CNS) involvement;
- •Severe or mild-degree ascitic fluid;
- •Main portal vein tumor thrombus;
- •Inferior venae cava tumor thrombus.
研究组 & 干预措施
Donafenib
Experimental
Drug:Donafenib; Dose:200mg,bid,po.
干预措施: Donafenib (Drug)
Sorafenib(Nexavar)
Active Comparator
Drug:Sorafenib; Dose:400mg,bid,po.
干预措施: Sorafenib (Drug)
结局指标
主要结局
Overall Survival
时间窗: 3 years
Patient visits are scheduled every 8 weeks to monitor efficacy.
次要结局
- Progress Free Survival(2 years)
- Percentage of adverse events(3 years)
研究者
研究点 (2)
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