NCT00812175已完成不适用
Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of Its Treatment With Sorafenib
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
- 3,371
- 主要终点
- The safety of Nexavar in all patients with unresectable HCC who are candidates for systemic therapy and in whom a decision to treat with Nexavar has been made under real-life practice conditions
研究概览
简要总结
In this international non-interventional study safety and clinical data concerning the treatment of patients suffering from Hepatocellular Carcinoma (HCC) will be collected.
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
- •Outpatients with histologically/cytologically documented or radiographically diagnosed unresectable HCC who are candidates for systemic therapy and for whom a decision to treat with Nexavar has been made. Radiographic diagnosis HCC NIS, needs typical findings of HCC by radiographic method i.e. on multi-dimensional, dynamic CT, CT hepatic arteriography (CTHA)/CT arterial portography (CTAP), or MRI.
- •Patients must have signed an informed consent form
- •Patients must have a life expectancy of at least 8 weeks
排除标准
- •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
The safety of Nexavar in all patients with unresectable HCC who are candidates for systemic therapy and in whom a decision to treat with Nexavar has been made under real-life practice conditions
时间窗: at each follow-up visit, every 2-4 months on average
次要结局
- Efficacy [overall survival (OS), progression-free survival (PFS), time to progression (TTP), response rate (RR), stable disease(SD) rate] by the Response Evaluation Criteria in Solid Tumor (RECIST) Criteria of Nexavar(at every visit, roughly every 2-4 months)
- The duration of therapy with Nexavar in a variety of settings according to patient characteristics and other variables(at every visit, roughly every 2-4 months)
- Reports of adverse events(at every visit, roughly every 2-4 months)
- To evaluate the methods of patient evaluation, diagnosis and follow up(at every visit, roughly every 2-4 months)
- To evaluate the co-morbidities in patients with unresectable HCC and their influence on treatment and outcome(at every visit, roughly every 2-4 months)
- To evaluate the practice patterns of the physicians involved in the care of patients with HCC under real-life conditions(at every visit, roughly every 2-4 months)
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