NCT00908752已完成3 期
A Randomized, Double-blind, Multicenter Phase III Study of Brivanib Versus Placebo as Adjuvant Therapy to Trans-Arterial Chemo-Embolization (TACE) in Patients With Unresectable Hepatocellular Carcinoma (The BRISK TA Study)
Bristol-Myers Squibb8 个研究点 分布在 2 个国家目标入组 734 人开始时间: 2009年7月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 734
- 试验地点
- 8
- 主要终点
- To compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy
研究概览
简要总结
The purpose of this study is to compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosis of hepatocellular carcinoma
- •Cirrhotic status of Child-Pugh Class A or B with a score of 7
- •ECOG performance status of 0 or 1
- •Adequate hematologic, hepatic, and renal function
- •Exclusion criteria:
- •Prior use of any systemic anticancer chemotherapy, immunotherapy, investigational or molecular targeted agents for HCC
- •History of cardiac disease
- •Active and untreated hepatitis B
- •Inability to swallow tablets or untreated malabsorption syndrome
- •History of human immunodeficiency virus (HIV) infection
排除标准
- 未提供
研究组 & 干预措施
Brivanib Placebo
Placebo Comparator
Placebo adjuvant treatment with TACE Therapy
干预措施: Brivanib Placebo (Other)
Brivanib
Active Comparator
Adjuvant treatment with TACE Therapy
干预措施: Brivanib (Drug)
Brivanib
Active Comparator
Adjuvant treatment with TACE Therapy
干预措施: TACE Therapy (Procedure)
Brivanib Placebo
Placebo Comparator
Placebo adjuvant treatment with TACE Therapy
干预措施: TACE Therapy (Procedure)
结局指标
主要结局
To compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy
时间窗: Survival will be assessed continuously
次要结局
- To compare the Time-To-Disease Progression (TTDP) of patients receiving brivanib with TACE therapy to that of patients receiving placebo with TACE therapy(Every 8 weeks)
- To compare the time to extrahepatic spread or vascular invasion in the brivanib and placebo arms(Every 8 weeks)
- To determine the total number of TACE sessions in the brivanib and placebo arms and to compare the rate of TACE sessions in the brivanib and placebo arms(End of Study)
- To evaluate the safety of brivanib in combination with TACE(Every 8 weeks)
研究者
研究点 (8)
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