跳至主要内容
临床试验/NCT01411436
NCT01411436已完成不适用

Special Drug Use Investigation of Nexavar (Unresectable Hepatocellular Carcinoma)

Bayer0 个研究点目标入组 1,637 人开始时间: 2009年5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
1,637
主要终点
Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar

研究概览

简要总结

This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Nexavar for unresectable hepatocellular carcinoma (HCC). The objective of this study is to assess safety and effectiveness of Nexavar under real-life practice conditions. This study is an all case investigation of which the enrollment period is 2 or 3 months (dependent on sites) for Child-Pugh A; for Child-Pugh B or C, the enrollment continues until agreement to stop with Pharmaceuticals Medical Devices Agency (PMDA). All patients who have received Nexavar will be recruited and followed one year since starting Nexavar administration.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who received Nexavar for unresectable hepatocellular carcinoma

排除标准

  • Patients who are contraindicated based on the product label

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

Incidence of adverse drug reactions and serious adverse events in subjects who received Nexavar

时间窗: After Nexavar administration, up to 1 year

次要结局

  • Demography(Baseline)
  • Effectiveness evaluation assessment [overall survival, complete response rate, partial response rate, stable disease rate] by the Response Evaluation Criteria in Solid Tumor (RECIST)(After Nexavar administration, up to 1 year)
  • Effectiveness evaluation assessment [time to progression, response rate, stable disease rate, progression rate] by investigator-determined overall best response(After Nexavar administration, up to 1 year)
  • The status of therapy with Nexavar [duration of treatment, daily dose] in a various settings according to baseline data [such as demographic data, Child-Pugh status, ECOG-PS](After Nexavar administration, up to 1 year)

研究者

发起方
Bayer
申办方类型
Industry
责任方
Sponsor

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