A Single-center, Prospective Cohort Study of Fruquintinib Combined With TAS-102 in Refractory Metastatic Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
Fruquintinib, as a standard treatment for refractory metastatic colorectal cancer (mCRC), has attracted increasing research efforts to explore its innovative strategies in combination with immunotherapy and chemotherapy because of its multi-target mechanism which enhances the sensitivity of the immune system and chemotherapy, aiming to further improve the survival benefits for mCRC patients. Trifluridine/tipiracil (TAS-102) is also a standard treatment for mCRC. This study aims to investigate the safety and effectiveness of the combined use of these two drugs in mCRC.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histology-confirmed metastatic CRC (mCRC)
- •Disease progression on standard therapy with at least two lines of chemotherapy, including fluorouracil, oxaliplatin, and irinotecan with or without biologics such as bevacizumab and cetuximab
- •Fruquintinib administered as salvage treatment
- •Age: 18-75 years old
- •Informed consent
排除标准
- •Liver or kidney dysfunction, or other conditions unsuitable for chemotherapy
- •Fruquintinib and/or TAS-102 administration as second-line treatment
- •Drug administration stopped after less than two cycles
研究组 & 干预措施
Fru plus TAS-102
mCRC patients receiveing Fruquintinib combined with TAS-102 in third- or late- line
干预措施: Fruquintinib Combined With TAS-102 (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: 3 years
PFS was calculated from the date of fruquintinib administration to the first observation of disease progression or death.
Overall Survival (OS)
时间窗: 3 years
OS was defined as the time from fruquintinib administration to death.
次要结局
未报告次要终点
研究者
Xu jianmin
Director of Colorectal Surgery
Fudan University