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NCT07614841Completed

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

Source: ClinicalTrials.gov · Last updated 29 May 2026

Brief summary (registry, in English)

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 .

Status (registry)
Completed
Study type
Observational
Enrollment
328 (actual)
First submitted
22 May 2026
Start date
1 Jan 2015
Primary completion date
31 Dec 2025
Lead sponsor
First Affiliated Hospital, Sun Yat-Sen University
NCT number
NCT07614841

What you commit to

  • Study type: Observational
  • Participants enrolled: 328
  • From 1 Jan 2015 to the primary completion date, 31 Dec 2025
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Those with poor medication adherence

Other

  • 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
  • Missing important diagnostic and treatment data

Who the study is looking for

  • 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

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.