Clinical trial · Observational
To Explore the Optimal Therapeutic Window for Imatinib in the Adjuvant Treatment of Intermediate and High-risk Gastrointestinal Stromal Tumors
NCT07614841CI-TRIAL-00112991completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 .
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Stromal Tumors (GISTs) | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- RFS
- timeFrame
- ten years
- description
- From patient enrollment to tumor recurrence or death for any reason
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.