Use of Sorafenib and/or Regorafenib in Hepatocellular Carcinoma (HCC) Subsequent to Another Systemic First-line Treatment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Bayer
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Identification of current treatment patterns by means of individual treatment lines in the systemic HCC therapy with regards to Nexavar and Stivarga, i.e. when both drugs are used in ≥ 2nd-line under current practice conditions
研究概览
简要总结
Researchers already did trials that showed Sorafenib and Regorafenib worked for patients with hepatocellular carcinoma (most common liver tumor type).
In this trial, they want to learn more about the same patient group in which Sorafenib or Regorafenib is given after other drugs. Patients participating in this study will be observed until 12 months after the last patient has been enrolled to collect data on how safe the drugs are and how well they are working when used as second line or beyond 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
- 否
入选标准
- •Diagnosis of hepatocellular cancer in stage BCLC-B or BCLC-C
- •Decision to initiate treatment with Nexavar (sorafenib) and/or Stivarga (regorafenib) as 2nd-line or beyond treatment was made as per investigator's routine treatment practice. Stivarga (regorafenib) must be used according to its indication, i.e. after prior progression under Nexavar (sorafenib) treatment.
排除标准
- •Patients concurrently participating in an investigational program for the treatment of HCC with interventions outside of routine clinical practice.
- •Stivarga (regorafenib) treatment without prior therapy with Nexavar (sorafenib). NOTE: Nexavar (sorafenib) treatment could have been given as treatment for HCC outside of this non-interventional study. In this case Stivarga (regorafenib) would NOT constitute the second-line therapy after direct pretreatment with Nexavar (sorafenib) but e.g. 3rd-line treatment directly after a different drug.
- •Contra-indications according to the local marketing authorization.
研究组 & 干预措施
Patients with HCC
Treated with Nexavar and/or Stivarga as ≥ 2nd-line systemic treatment
干预措施: Regorafenib (Stivarga, BAY73-4506) (Drug)
Patients with HCC
Treated with Nexavar and/or Stivarga as ≥ 2nd-line systemic treatment
干预措施: Sorafenib (Nexavar, BAY43-9006) (Drug)
结局指标
主要结局
Identification of current treatment patterns by means of individual treatment lines in the systemic HCC therapy with regards to Nexavar and Stivarga, i.e. when both drugs are used in ≥ 2nd-line under current practice conditions
时间窗: Up to 24 months
次要结局
- Overall Survival (OS) from start of Nexavar or Stivarga therapy and from start of first systemic therapy(Up to 36 months)
- Incidence of treatment-emergent adverse events (TEAE)(Up to 36 months)
- Progression free survival (PFS)(Up to 36 months)
- Time to progression (TTP)(Up to 36 months)
- Duration of Nexavar or Stivarga treatment(Up to 36 months)
- Tumor response to treatment(Up to 36 months)