跳至主要内容
临床试验/NCT00792350
NCT00792350已完成不适用

International Study With Nexavar About Safety and Efficacy in Carcinoma Hepatocellular Therapy (HCC)

Bayer0 个研究点目标入组 791 人开始时间: 2008年4月最近更新:
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

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

发起方
Bayer
申办方类型
Industry
责任方
Sponsor

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