Fruquintinib in Refractory Metastatic Colorectal Cancer: A Real-world Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 520
- 试验地点
- 1
- 主要终点
- OS
研究概览
简要总结
Fruquintinib is an oral tyrosine kinase inhibitor (TKI), which improves progression-free survival (PFS) and overall survival (OS) in patients with refractory metastatic colorectal cancer (mCRC). Here, we explore the real-world treatment patterns of fruquintinib in the third- or late-line setting for mCRC in six centers in China.
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
- •(1) histology-confirmed metastatic CRC (mCRC); (2) 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; (3) fruquintinib administered as salvage treatment; (4) available clinical data.
排除标准
- •(1) lack of follow-up data; (2) fruquintinib administration as second-line treatment; (3) fruquintinib administration stopped after less than two cycles.
研究组 & 干预措施
monotherapy group
patients received fruquintinib alone
干预措施: Fruquintinib (Drug)
combine group
patients administered fruquintinib in combination with chemotherapy or/and anti-PD1 antibodies
干预措施: Fruquintinib (Drug)
结局指标
主要结局
OS
时间窗: Three years
OS was defined as the time from fruquintinib administration to death
PFS
时间窗: Three years
PFS was calculated from the date of fruquintinib administration to the first observation of disease progression or death
DCR
时间窗: During the medication period
DCR was determined as the proportion of patients who achieved complete response, partial response or stable disease assessed at least 6 weeks after drug administration
次要结局
未报告次要终点
研究者
Xu jianmin
Director of Colorectal Surgery
Fudan University