Skip to main content
OpenTrials
Completed

NCT Number: NCT07614841

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

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 .

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastrointestinal Stromal Tumors (GISTs) Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Missing important diagnostic and treatment data

Treatment and study plan

Primary outcomes

  1. RFS

    Time frame: ten years

    From patient enrollment to tumor recurrence or death for any reason

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Important dates

Study start
2015
Primary completion
2025
Study completion
2025
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.