A Real-world Study of Fruquintinib in the Cross-line Treatment of Refractory mCRC
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Overall survival 2(OS2)
研究概览
简要总结
This is a real-world study. Patients with metastatic colorectal cancer who have progressed (PD) after third-line treatment with fruquintinib combined with PD-1 inhibitors will receive fruquintinib combined with TAS-102 as fourth-line therapy. The objective of this study was to observe the efficacy and safety of cross-line（from third to fourth line）treatment with fruquinitinib.
详细描述
This is a real-world study. Patients with metastatic colorectal cancer confirmed by histopathology had previously received 2-line system therapy with fluorouracil, oxaliplatin, irinotecan, anti-VEGF, anti-EGFR (RAS and BRAF wild type) (treatment with anti-VEGF-TKI is not allowed), and had received fruquinitinib combined with PD-1 inhibitors for third-line treatment. After progression (PD) (confirmed by RECIST 1.1 ), fruquinitinib combined with TAS-102 as fourth-line therapy was received. The primary endpoint was observation the overall survival (OS) of fourth-line treatment of mCRC with fruquinitinib and TAS-102. The study objective is to explore the possibility of cross-line rechallenge of fruquinitinib.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •To be enrolled in this study, patients must meet all of the following criteria:
- •Age ≥18 years, ≤75 years;
- •No gender limitation;
- •Patients with metastatic colorectal cancer confirmed by histopathology had previously received 2-line system therapy with fluorouracil, oxaliplatin, irinotecan, anti-VEGF, anti-EGFR (RAS and BRAF wild type) (treatment with anti-VEGF-TKI is not allowed), and had received fruquinitinib combined with PD-1 inhibitors for third-line treatment. After progression (PD) (confirmed by RECIST 1.1 ), fruquinitinib combined with TAS-102 as fourth-line therapy was received.
- •Expected survival ≥12 weeks
- •Must have at least one measurable lesion (RECIST1.1).
- •Full organ and bone marrow function.
排除标准
- •Patients will not be admitted to the study if they meet any of the following criteria:
- •Patients with contraindications to study drugs (fruquinitinib, PD-1 inhibitor, TAS-102);
- •allergic to the investigational drug or any of its adjuncts;
- •There are other non-investigational drugs during third-line and fourth-line treatment;
- •Pregnant or lactating female subjects;
- •Patients with a large number of pleural effusion or ascites requiring drainage;
- •Patients considered unsuitable for inclusion in this study by the investigators.
研究组 & 干预措施
Fruquintinib Rechallenge
- third-line treatment with fruquintinib combined with PD-1 inhibitors
- fourth-line treatment with fruquintinib combined with TAS-102
干预措施: Fruquintinib+PD-1 inhibitors (Drug)
Fruquintinib Rechallenge
- third-line treatment with fruquintinib combined with PD-1 inhibitors
- fourth-line treatment with fruquintinib combined with TAS-102
干预措施: Fruquintinib+TAS-102 (Drug)
结局指标
主要结局
Overall survival 2(OS2)
时间窗: From the date of first fruquinitinib combined with TAS-102 treatment until the date of first documented date of death from any cause , assessed up to 12 months
Overall survival (OS) of fourth-line treatment of mCRC with fruquinitinib and TAS-102
次要结局
- Objective response rate 2(ORR2, investigator based on RECIST1.1)(from received fruquinitinib combined with TAS-102 to one year)
- Progression-free survival 2(PFS2, investigators based on RECIST1.1)(From the date of first fruquinitinib combined with TAS-102 treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months)
- Disease control rate 2 (DCR2, investigators based on RECIST1.1)(from received fruquinitinib combined with TAS-102 to one year)
研究者
Zhenyu Lin
associate chief physician
Wuhan Union Hospital, China