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Study aims to pinpoint ideal imatinib dose for GIST patients

NCT ID NCT07614841

Knowledge-focused Sponsor: First Affiliated Hospital, Sun Yat-Sen University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study looked at 328 patients with intermediate or high-risk gastrointestinal stromal tumors (GISTs) who took imatinib after surgery. The goal was to find the best dose that balances effectiveness in preventing tumor return with the risk of side effects. Researchers measured drug levels in the blood and tracked how long patients stayed cancer-free.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
imatinib
What this could lead to
If successful, this could help doctors find the safest and most effective dose of imatinib for GIST patients after surgery.
What could go wrong
This is an observational study, not a controlled trial, so results may not prove cause and effect. The findings may not apply to all GIST patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

328 people

The number who actually took part.

Started

Jan 2015

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients using imatinib as adjuvant therapy for GIST

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients using imatinib as adjuvant therapy for GIST from 2015\~2025 2. ECOG (Eastern Cooperative Oncology Group performance status) physical fitness score ranges from 0 to 4 3. Local GIST diagnosis confirmed by histology 4. The surgical resection type of primary GIST (R0 / R1) was documented 5. Regular long-term maintenance doses of imatinib at steady-state trough concentrations ≥ 3 times Exclusion Criteria: 1. 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 2. Those with poor medication adherence 3. Missing important diagnostic and treatment data

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Conditions

The condition(s) this trial relates to.

gastrointestinal stromal tumor

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastrointestinal stromal tumors (gists)

More trials for these conditions

Other studies related to the condition(s) this trial covers.