NCT01539681已完成不适用
Sorafenib Treatment Modalities for HEpatoceLLular Carcinoma Patients in ItAly
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
- 234
- 主要终点
- Efficacy (analyzed by overall survival rate) of sorafenib under real-life practice conditions in patients with Hepatocellular Carcinoma.
研究概览
简要总结
Prospective, non-interventional, multi-center study. Patients affected by Hepatocellular Carcinoma (HCC) who are candidates for systemic therapy and in whom a decision to treat with sorafenib has been made. Aim of this non-interventional, post-marketing study is to evaluate the efficacy of sorafenib in terms of overall survival rate at 12 months in patients with HCC under daily-life treatment conditions.
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
- •Patients with histologically/cytologically confirmed HCC or radiographically diagnosed as per AASLD criteria, who are candidates for systemic therapy and for whom a decision to treat with sorafenib has been made
- •Patients must have signed the informed consent form
- •Patients must have a life expectancy of at least 8 weeks Inclusion criteria must follow the approved local product information.
排除标准
- •Prior treatment with sorafenib
- •Concomitant participation in other clinical studies Exclusion criteria must follow the approved 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 (analyzed by overall survival rate) of sorafenib under real-life practice conditions in patients with Hepatocellular Carcinoma.
时间窗: at 1 year
次要结局
- Adverse event collection of sorafenib under real-life practice conditions in patients with Hepatocellular Carcinoma.(every 4 months on average within approx. 2 years)
- Overall survival(at 1 year)
- Time to Progression(every 4 months on average within approx. 2 years)
研究者
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