A Randomized, Open Label, Multicenter Phase 2 Study, to Evaluate the Efficacy of Sorafenib in Patients With Advanced Renal Cell Carcinoma (RCC) After a Radical Resection of the Metastases
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 132
- 试验地点
- 14
- 主要终点
- Recurrence Free Survival
研究概览
简要总结
Evaluate the efficacy and tolerability of sorafenib in RCC patients underwent to metastasectomy
详细描述
Advanced RCC presents poor prognosis, because its pathogenesis is not clearly understood. However, up-regulation of the Ras pathway is thought to play a role.
VEGF expression could represent independent prognostic factors for survival possibly linking expression of this protein with clinical outcome.
Sorafenib is a potent inhibitor of both Raf-kinase and VEGF R2 signalling The anti-tumoral activity of Sorafenib was clearly demonstrated in phase III trial regarding advanced pretreated RCC.
Surgical removal of metastatic disease could potentially increase the disease control rate.
Particularly in patients with a disease free interval post nephrectomy of at least 1 year, with one small metastatic lesion, metastasectomy could represents an important therapeutic approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sorafenib
Active Arm
干预措施: sorafenib (Drug)
结局指标
主要结局
Recurrence Free Survival
时间窗: December 2011 - December 2014 (3 years)
Efficacy of Sorafenib compared with BSC, in RCC patients that have undergone radical resection of recurrent metastatic disease, after prior nephrectomy. The primary efficacy endpoint is Recurrence Free Survival (RFS),
次要结局
- Safety Profile(December 2011 - December 2014 (3 years))
- Overall Survival(December 2011 - December 2014 (3 years))
- Vascular endothelial growth factors (VEGF) levels in BSC and Sorafenib arm.(December 2011 - December 2014 (3 years))