CompletedNot Applicable

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

328 participantsStarted 2015-01-01

Plain-language summary

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 .

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

RFS

Timeframe: ten years

Trial details

NCT IDNCT07614841

SponsorFirst Affiliated Hospital, Sun Yat-Sen University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Gastrointestinal Stromal Tumors (GISTs) trials