Phase III Study of BAY43-9006 in Patients With Advanced Hepatocellular Carcinoma (HCC) Treated After Transcatheter Arterial Chemoembolization (TACE)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 458
- 主要终点
- Time to Progression (TTP)
研究概览
简要总结
Clinical trial of BAY43-9006 in patients with hepatocellular carcinoma.
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
- Triple (Participant, 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
- •Male or female
- •Aged of 18 and over
- •Advanced hepatocellular carcinoma
排除标准
- •History of prior systemic chemotherapy
- •Failure in vital organ
研究组 & 干预措施
Sorafenib (Nexavar, BAY43-9006)
Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
干预措施: Sorafenib (Nexavar, BAY43-9006) (Drug)
Placebo
Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Progression (TTP)
时间窗: From randomization of the first subject until radiological progression or recurrence whichever came first, assessed up to 39 months.
Time to progression (TTP) was defined as the time from date of randomization to radiological progression / recurrence. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation.
次要结局
- Overall Survival (OS)(From randomization of the first subject until 39 months later.)