Regorafenib Treatment Patterns and Survival Outcomes in Advanced Colorectal Cancer: A Real-world Study
试验速览
- 阶段
- 不适用
- 入组人数
- 650
- 试验地点
- 2
- 主要终点
- 6-month Overall Survival rate
研究概览
简要总结
This is a multi-center, retrospective, real-world study. The purpose of this study is to observe the effectiveness and safety of regorafenib in Chinese advanced colorectal cancer patients.
The main observational goals include overall survival(OS), 6 month OS rate, 1 year OS rate, and treatment time failure (TTF), other study goals include objective response rate( ORR)、Disease control rate（DCR）and adverse event(AE) of regorafenib.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Patients with colorectal cancer confirmed by pathological tissue or cytology；
- •The pathological type of colorectal tumor was adenocarcinoma；
- •Patients with recurrent or metastatic, unresectable advanced colorectal cancer；
- •Patients who received regorafenib at least one period treatment.
排除标准
- •Patients participating in other interventional clinical studies while taking regorafenib;
- •Patients with other malignant tumors within 5 years before regorafenib treatment, except for cured cervical carcinoma in situ, skin squamous cell carcinoma or basal cell carcinoma, early papillary thyroid carcinoma, etc.;
- •The investigator deems that there are other factors that are not suitable for patients who participate in this study.
结局指标
主要结局
6-month Overall Survival rate
时间窗: 6 month
6 months OS rate of patients who received regorafenib treatment.
1 year Overall Survival rate
时间窗: 1 year
1 year OS rate of patients who received regorafenib treatment.
overall survival
时间窗: 1 year
overall survival of patients who received regorafenib treatment.
次要结局
- objective response rate(1 year)
- Disease control rate(1 year)
- Incidence of Adverse Events (AEs)(1 year)
研究者
Aiping Zhou
Chief Physician
Chinese Academy of Medical Sciences