SORINT - SORafenib for Treatment of Patients With INTermediate Stage Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 19
- 主要终点
- Distribution of intermediate stage hepatocellular carcinoma (HCC) patients treated with Nexavar to different treatment groups will be evaluated by the relative frequency of patients in each treatment group.
研究概览
简要总结
The study aims to investigate patient characteristics of intermediate stage hepatocellular carcinoma patients treated with Nexavar and their distribution to different treatment groups as well as determining efficacy and safety parameters.
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 a diagnosis of unresectable intermediate stage hepatocellular carcinoma (BCLC-B) for whom the decision has been taken by the investigator to prescribe Nexavar (the BCLC intermediate stage (BCLC-B) consists of Child-Pugh A and B patients with large/multifocal HCC who do not have cancer related symptoms, macrovascular invasion or extrahepatic spread).
排除标准
- •Prior targeted therapy for hepatocellular carcinoma.
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
Distribution of intermediate stage hepatocellular carcinoma (HCC) patients treated with Nexavar to different treatment groups will be evaluated by the relative frequency of patients in each treatment group.
时间窗: up to 54 months
Characteristics of patients with intermediate stage HCC (BCLC-B) treated with Nexavar will be determined by evaluating demographic data, medical history, previous treatment of HCC, specific concomitant conditions (amongst others).
时间窗: up to 54 months
次要结局
- Time to progression is defined as the time interval from start of Nexavar therapy to the date of diagnosed progression.(up to 54 months)
- Time to treatment failure is defined as the time interval from start of Nexavar therapy to the date of diagnosed progression or permanent discontinuation due to toxicity.(up to 54 months)
- Tumor status at different visits will be evaluated according to radiological or clinical evaluation. The best overall response will be analyzed providing absolute and relative frequencies of the tumor status categories.(up to 54 months)
- Further possible prognostic factors will be evaluated.(up to 54 months)
- Safety variables will be summarized using descriptive statistics based on adverse events collection.(up to 54 months)
- Overall Survival is measured as the time interval from start of Nexavar therapy to the date of death, due to any reason.(up to 54 months)
- Duration of Nexavar treatment is measured as the time interval from start of Nexavar therapy to the date of permanent discontinuation of Nexavar therapy (regardless of the reason for discontinuation).(up to 54 months)
- Progression free survival is measured as the time interval from the start of Nexavar treatment to diagnosed (radiological or clinical) progression or death, whichever comes first.(up to 54 months)