Randomized Phase III Trial Sorafenib-Pravastatin Versus Sorafenib Alone for the Palliative Treatment of Child-Pugh A Hepatocellular Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 323
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Sorafenib tosylate and pravastatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib tosylate may also stop the growth of liver cancer by blocking blood flow to the tumor. It is not yet known whether sorafenib tosylate is more effective when given alone or together with pravastatin in treating patients with liver cancer and cirrhosis.
PURPOSE: This randomized phase III trial is studying sorafenib tosylate given together with pravastatin to see how well it works compared with giving sorafenib tosylate alone in treating patients with liver cancer and cirrhosis.
详细描述
OBJECTIVES:
Primary
- To evaluate the effects of sorafenib tosylate and pravastatin versus sorafenib tosylate alone on overall survival of patients with hepatocellular carcinoma and Child-Pugh Class A cirrhosis.
Secondary
- To evaluate the effect of this regimen on progression-free survival, time to progression, time to treatment failure, and quality of life (QLQ-C30 and FACT hep) in these patients.
- To evaluate the benefit of on-site monitoring versus the centralized data management monitoring of these patients.
- To characterize polymorphisms to specify the haplotype diversity in these patients.
- To test both diagnostic and prognostic signatures by quantitative RT-PCR to determine if they can predict response to these regimens.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
sorafenib
sorafenib
干预措施: sorafenib tosylate (Drug)
sorafenib + pravastatine
sorafenib + pravastatine
干预措施: pravastatin sodium (Drug)
sorafenib + pravastatine
sorafenib + pravastatine
干预措施: sorafenib tosylate (Drug)
结局指标
主要结局
Overall survival
时间窗: 2014
次要结局
- Time to progression(2014)
- Progression-free survival(2014)