NCT00792350已完成不适用
International Study With Nexavar About Safety and Efficacy in Carcinoma Hepatocellular Therapy (HCC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 791
- 主要终点
- Efficacy: status of tumor, patients performance status
研究概览
简要总结
In this international non-interventional post-marketing surveillance study we want to evaluate patient characteristics in HCC patients as well as efficacy and safety of Sorafenib (Nexavar®) treatment under daily-life treatment conditions. Specifically investigated are the tumor status, prior and/ or concomitant surgical, radiological and drug treatment and the duration of Sorafenib treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •In- and outpatients with diagnosis of hepatocellular carcinoma (HCC) and decision taken by the investigator to prescribe Nexavar
排除标准
- •Exclusion criteria must be read in conjunction with the local product information
研究组 & 干预措施
Group 1
干预措施: Sorafenib (Nexavar, BAY43-9006) (Drug)
结局指标
主要结局
Efficacy: status of tumor, patients performance status
时间窗: At each follow-up visit, every 2-4 months
次要结局
- Duration of treatment(At each follow-up visit, every 2-4 months)
- Time of survival(At each follow-up visit, every 2-4 months)
- Reports of adverse events(At each follow-up visit, every 2-4 months)
研究者
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