A National Multicenter, Noninterventional Clinical Study Evaluating the Safety and Efficacy of Avapritinib in Chinese Patients With Gastrointestinal Stromal Tumor (GIST) in the Real World
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Dose adjustment of avapritinib in cohort 1, 2, and 3
研究概览
简要总结
This study is an observational, multicenter, Real-word study to evaluate the safety and clinical efficacy of avapritinib in Chinese subjects with GIST.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Cohort 1 and 4: Participants must have a confirmed diagnosis of unresectable GIST with mutations in the PDGFRα gene exon
- •Cohort 2: Participants must have a confirmed diagnosis of GIST with mutations in the PDGFRα gene exon 18 and was/will be administrated avapritinib in an neoadjuvant and/or adjuvant setting.
- •Cohort 3: Participants must have a confirmed diagnosis of unresectable GIST without mutations in the PDGFRα gene exon 18, KIT gene exon 13, and KIT gene exon 14.
排除标准
- •Participants who have participated and may participate in any other interventional clinical trail in the future.
- •Participants with any comorbidities not suitable for avapritinib (other TKIs, Cohort 4) treatment assessed by researchers.
研究组 & 干预措施
TKI
Unresectable or metastatic PDGFRA exon 18 GIST
干预措施: Tyrosine kinase inhibitors other than avapritinib ( imatinib, sunitinib, et al ) (Drug)
Ava-mGSIT-P18
Unresectable or metastatic PDGFRA exon 18 GIST
干预措施: Avapritinib (Drug)
Ava-Perioperative
Perioperative PDGFRA exon 18 GIST
干预措施: Avapritinib (Drug)
Ava-mGIST-other
Unresectable or metastatic GIST without KIT exon 13，14，or PDGFRA exon 18 mutation
干预措施: Avapritinib (Drug)
结局指标
主要结局
Dose adjustment of avapritinib in cohort 1, 2, and 3
时间窗: From the start of study drug until 30 days after the last dose, up to 3 years.
Incidence and severity of adverse events(AE) and serious adverse events(SAE)in cohort 1, 2, and 3
时间窗: AEs were collected from the start of study drug until 30 days after the last dose, SAEs were collected from the date of the informed consent signature until 30 days after the last dose of study drug, up to 3 years.
次要结局
未报告次要终点