To Explore the Optimal Therapeutic Window for Imatinib in the Adjuvant Treatment of Intermediate and High-risk Gastrointestinal Stromal Tumors

First Affiliated Hospital, Sun Yat-Sen University0 个研究点目标入组 328 人开始时间: 2015年1月1日最近更新: 2026年5月29日

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 328

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

The goal of this observational study is to explore the quantitative relationship between in vivo exposure and efficacy, and the relationship between in vivo exposure and the risk of adverse reactions after adjuvant treatment of imatinib in patients with intermediate and high-risk GIST in the real world, so as to determine the optimal treatment window for imatinib .

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

•Patients using imatinib as adjuvant therapy for GIST from 2015~2025
•ECOG (Eastern Cooperative Oncology Group performance status) physical fitness score ranges from 0 to 4
•Local GIST diagnosis confirmed by histology
•The surgical resection type of primary GIST (R0 / R1) was documented
•Regular long-term maintenance doses of imatinib at steady-state trough concentrations ≥ 3 times

排除标准

•Known GISTs insensitive to imatinib, such as PDGFRA exon 18 D842V mutation, KIT exon 17 mutation, SDH-deletion type, NF-1 mutation, and NTRK fusion mutation
•Those with poor medication adherence
•Missing important diagnostic and treatment data

研究者

发起方

First Affiliated Hospital, Sun Yat-Sen University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Xinhua Zhang, MD

Director

First Affiliated Hospital, Sun Yat-Sen University

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