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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07614841

Enrollment

328

Registered

2026-05-29

Start date

2015-01-01

Completion date

2025-12-31

Last updated

2026-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Stromal Tumors (GISTs)

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 .

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
RFS	ten years	From patient enrollment to tumor recurrence or death for any reason

Outcome results