A Large Scale, Multicenter, Real-World Study on Patients With Advanced GIST Receiving Ripretinib
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 308
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
to evaluate the clinical efficacy, safety and predictive factors of ripetinib in Chinese patients with advanced GIST in the real world
详细描述
Ripretinib has become the standard ≥ 4L treatment in advanced GIST. Given the small sample size of patients in the China bridging study of INVICTUS as well as the short marketing time of ripretinib, further exploration on the long-term efficacy and safety of ripretinib, as well as the dominant gene mutation type of ripretinib in Chinese GIST patients is required. Hence, we plan to further explore the efficacy of ripretinib, predictors of efficacy, etc. by collecting and analyzing real-world data from Chinese patients with advanced GIST recieving ripretinib.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old
- •Histologically confirmed gastrointestinal stromal tumor (GIST)
- •At least one measurable lesion (mRECIST v1.1)
- •Received or receiving ripretinib treatment
排除标准
- •Patients who received <1 cycle of ripretinib treatment
- •Medical records are incomplete
结局指标
主要结局
PFS
时间窗: approximately 7 months
To assess the efficacy (progression-free survival \[PFS\]
次要结局
- OS(approximately 12 months)
- DCR(approximately 6 months)
研究者
Shen Lin
Director of GI oncology Affiliation: Peking University, Peking University
Peking University