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

NCT07614841 | Completed

• 1 other identifier: No.[2026]337
• Study Type: observational
• Target: 328
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

Gastrointestinal Stromal Tumors (GISTs)

Outcome Measures

Primary Outcomes (1)

• RFS

  From patient enrollment to tumor recurrence or death for any reason

  ten years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients using imatinib as adjuvant therapy for GIST

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start: January 1, 2015
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share