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Clinical Trials/NCT07614841
NCT07614841CompletedNot Applicable

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 sites328 target enrollmentStarted: January 1, 2015Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
328
Study OverviewStudy DesignEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief 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 .

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Investigators

Sponsor
First Affiliated Hospital, Sun Yat-Sen University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Xinhua Zhang, MD

Director

First Affiliated Hospital, Sun Yat-Sen University

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