Fruquintinib-based Treatment for Refractory Bone and Soft Tissue Sarcomas After Several Lines of TKIs' Resistance:A Multicenter Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
This multicenter retrospective study assessed the efficacy and safety of fruquintinib-based treatment in patients with refractory bone and soft tissue sarcomas after several lines of TKIs' resistance.
详细描述
The short-lived duration of disease control and secondary drug resistance have posed a threat to the effect of TKIs. Fruquintinib is a novel TKI with a high selectivity of VEGFR-1,2,3 without metabolism by liver enzymes and was approved for application in mCRC. Serious drug resistance and the unique characteristics of fruquintinib have prompted us to verify whether this drug can reverse TKIs' resistance at a higher dose.
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 confirmed bone or soft tissue sarcomas;
- •Progressed after several lines of therapy;
- •Previously treated with other TKIs before fruquintinib;
- •Received fruquintinib-based treatment;
- •Measurable lesions according to the Response Evaluation Criteria for Solid Tumors (RECIST) version1.1;
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤3
排除标准
- •Failure to complete regular follow-up after administration.
- •Discontinued the fruquintinib-based treatment due to neither progression nor unacceptable toxicity.
研究组 & 干预措施
Study group
Fruquintinib treatment group
干预措施: Fruquintinib (Drug)
结局指标
主要结局
PFS
时间窗: 4months
The time from the first administration of fruquintinib to the date of first documentation of disease progression or death, whichever occurred first.
次要结局
- OS(1year)
- ORR(1year)
- DCR(1year)
- AEs(1year)
研究者
Xie Lu
Principal Investigator
Peking University People's Hospital