Sunitinib Intake Conditions in the Treatment of Patients With Renal Cell Carcinoma: a Multicenter, Non-interventional, Retrospective Survey
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Disease control rate (DCR)
研究概览
简要总结
This non-interventional study includes patients with advanced renal cell carcinoma who are treated with Sunitinib alone or combined with other systemic therapies. The aim of the trial is to increase knowledge about usage, dosage, efficacy and safety under conditions of routine use of Sunitinib.
详细描述
Because State Food and Drug Administration (SFDA) exempted manufacturers from conducting clinical trials of Sunitinib in China, overall efficacy and safety data of Sunitinib in Chinese patients with renal cell carcinoma were deficiency. The investigators carried out this research project will be sufficient evidence, and help clinicians in China to make decision in real daily practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed, unresectable advanced renal cell carcinoma;
- •Sunitinib as first-line treatment alone or combined with other therapies.
排除标准
- •History of Grade 3/4 severe allergic reaction to Sunitinib or its metabolites
结局指标
主要结局
Disease control rate (DCR)
时间窗: 2008-2011 (up to 3 years)
* To determine the Disease control rate (DCR) defined as the percentage of patients who have a partial response (CR) or complete response (PR) to Sunitinib plus those whose disease is stable (DS). * To determine the Objective Responsive Rate (ORR) defined as the percentage of patients who have a partial response (PR) or complete response (CR) to Sunitinib.
次要结局
- Progression Free survival (PFS)(2008 - 2011 (up to 3 years))
- Overall Survival (OS)(2008 - 2011 (up to 3 years))
- Number of patients with adverse events(2008 - 2011 (up to 3 years))