REFINE: Regorafenib Observational Study in Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 1,010
- 试验地点
- 18
- 主要终点
- Number of patients with treatment emergent adverse events (TEAEs) leading to dose modifications (including reductions, interruptions and permanent discontinuation)
研究概览
简要总结
Observational study to evaluate, under real-world practice conditions, the safety and effectiveness of regorafenib in patients diagnosed with unresectable hepatocellular carcinoma (uHCC)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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 with confirmed diagnosis of unresectable HCC
- •Physician-initiated decision to treat with regorafenib (prior to study enrollment)
排除标准
- •Participation in an investigational program with interventions outside of routine clinical practice
- •Past treatment with regorafenib
研究组 & 干预措施
uHCC patients treated with regorafenib
Patients with a confirmed diagnosis of uHCC and for whom a decision to treat with regorafenib has been made (by the treating physician)
干预措施: Regorafenib (Stivarga, BAY73-4506) (Drug)
结局指标
主要结局
Number of patients with treatment emergent adverse events (TEAEs) leading to dose modifications (including reductions, interruptions and permanent discontinuation)
时间窗: Up to 24 months
The primary endpoint is the safety of regorafenib in patients with uHCC, defined as the frequency of documented TEAEs, including serious adverse events (SAEs). Safety will be assessed in all patients who receive at least one dose of regorafenib regardless of prior treatment.
次要结局
- Overall survival (OS)(Up to 24 months)
- Progression-free survival (PFS)(Up to 24 months)
- Time to progression (TTP)(Up to 24 months)
- Best overall tumor response (ORR)(Up to 24 months)
- Duration of regorafenib treatment(Up to 24 months)