Multicenter, Prospective, Non-interventional Study "Sorafenib as Neoadjuvant Therapy Before Cytoreductive Nephrectomy in Patients With Metastatic Renal Cell Carcinoma"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 61
- 主要终点
- Maximum percent reduction (based on the minimum post baseline value) in the longest diameter of the primary tumor in response to neoadjuvant Nexavar treatment.
研究概览
简要总结
This local, prospective, multicenter, non-interventional study documents observational data on patients under routine treatment of metastatic RCC with Nexavar before and after cytoreductive nephrectomy. It's planned to better understand the impact of cytoreductive nephrectomy on Nexavar efficacy and possibly to define patients who get the most benefit from Nexavar before cytoreductive nephrectomy.
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
- •- Male and female patients ≥ 18 years old
- •Patients with untreated metastatic RCC in whom a decision on neoadjuvant treatment with Nexavar before cytoreductive nephrectomy and in case of clinical feasibility resumption of treatment with Nexavar after nephrectomy has been made at the time of study enrollment
- •Life expectancy of at least 16 weeks
- •Patients should have signed informed consent form
排除标准
- •Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer.
- •All contra-indications according to the Russian marketing authorization:
- •Hypersensitivity to sorafenib or to any of the excipients.
- •Pregnancy and breast-feeding.
- •Age less than 18 years.
研究组 & 干预措施
Group 1
干预措施: Sorafenib (Nexavar, BAY 43-9006) (Drug)
结局指标
主要结局
Maximum percent reduction (based on the minimum post baseline value) in the longest diameter of the primary tumor in response to neoadjuvant Nexavar treatment.
时间窗: up to 2 years
Response rate of residual disease to Nexavar according to RECIST 1.1 with baseline after cytoreductive nephrectomy.
时间窗: up to 2 years
次要结局
- Maximum percent reduction in the sum of longest diameters of target lesions of residual disease after cytoreductive nephrectomy according to RECIST 1.1 while on Nexavar treatment with baseline after cytoreductive nephrectomy.(up to 2 years)
- Response before cytoreductive nephrectomy according to RECIST 1.1.(up to 2 years)
- Number of participants with AEs, including intra- and postoperative complications, relation to Nexavar treatment, AEs treatment, AEs outcome.(up to 2 years)
- Maximum percent reduction in the sum of longest diameters of target lesions according to RECIST 1.1 while on Nexavar treatment before cytoreductive nephrectomy(up to 2 years)