A Single-center，Observational，Ambispective Cohort Study of Regorafenib Versus Fruquintinib in Metastatic Colorectal Cancer Patients Who Have Progressed After at Least Second Lines of Chemotherapies
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 268
- 试验地点
- 1
- 主要终点
- Time To Treatment Failure
研究概览
简要总结
This is an observational, ambispective cohort study. The aim is to compare the efficacy and safety of regorafenib versus fruquintinib conducted in China. About 268 eligible metastatic colorectal cancer patients after second-line therapy will be assigned to receive either regorafenib or fruquintinib, based on decision of the gastrointestinal physician according the patients' condition.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed and dated informed consent.
- •Diagnosis of histologically confirmed colorectal cancer, stage IV.
- •after second-line therapy.
- •gastrointestinal physician prescribed to receive regorafenib or fruquintinib according the patients' condition.
排除标准
- •received regorafenib or fruquintinib before third-line therapy.
- •the clinicopathological characteristics and previous therapy were unknown.
- •regorafenib or fruquintinib treatment is less than one cycle in the historical cohort.
研究组 & 干预措施
Regorafenib
干预措施: Regorafenib (Drug)
Fruquintinib
干预措施: Fruquintinib (Drug)
结局指标
主要结局
Time To Treatment Failure
时间窗: every month, up to discontinuation of treatment for any reason.
the time from first dose to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.
次要结局
- Overall survival(from enrollment of the first subject until the database cut-off approximately 6 months later.)
- Progression-free survival(from enrollment of the first subject until the database cut-off approximately 6 months later.)
- Incidence of adverse events（AEs）(from the first dose to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.)
研究者
Shen Lin
MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital
Peking University