A Randomized, Double-Blind, Placebo-Controlled Phase III Trial Of TSU-68 In Combination With Transcatheter Arterial Chemoembolization In Patients With Unresectable Hepatocellular Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 888
- 试验地点
- 1
- 主要终点
- Overall Survival(OS)
研究概览
简要总结
The purpose of this study is to compare the overall survival (OS) for Orantinib in combination with transcatheter arterial chemoembolization (TACE) versus placebo in combination with TACE in patients with unresectable hepatocellular carcinoma (HCC).
详细描述
This is a randomized, multi-center, double-blind, placebo-controlled phase III trial of Orantinib administered in combination with TACE in patients with unresectable HCC.
Patients will be randomly assigned (1:1) to receive TACE given in combination with either Orantinib (200 mg orally, twice per day) or placebo.
ORIENTAL:ORantinib InvEstigatioN on TAce combination triaL.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be diagnosed as HCC.
- •Patients has no indications for treatment with curative hepatic resection or curative percutaneous local therapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or
- •Patients are able to receive oral medication.
排除标准
- 未提供
研究组 & 干预措施
Orantinib
干预措施: Orantinib (TSU-68) (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Survival(OS)
时间窗: The time from the date of enrollment to the date of death from any cause, assessed up to three years after randomizationof the last patient
次要结局
- Time to Transcatheter Arterial Chemoembolization (TACE) Failure(The time from the date of enrollment to the date of event for TACE discontinuation, assessed up to three years after randomizationof the last patient)