Special Drug Use Investigation of Nexavar (Unresectable Hepatocellular Carcinoma)
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
- 否
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)