OncoMatch/Clinical Trials/NCT05385549
5 Years of Adjuvant Imatinib in Patients With Gastrointestinal Stromal Tumor With a High Risk
Is NCT05385549 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Imatinib Mesylate for gastrointestinal stromal tumors.
Treatment: Imatinib Mesylate — In this study, the investigators aim to investigate the efficacy and safety of 5 years of adjuvant imatinib treatment in patients with tumor rupture defined by Nishida classification or those with a tumor size 10cm or larger and a mitotic index of 10/50HPFs or higher.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Gastrointestinal Stromal Tumor
Biomarker criteria
Required: KIT mutation
mutation in KIT or PDGFRα gene
Required: PDGFRA mutation
mutation in KIT or PDGFRα gene
Excluded: PDGFRA D842V
The patients with PDGFRα D842V mutation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Lab requirements
Blood counts
neutrophil >1,500/mm3; platelet > 100,000/mm3; hemoglobin >8.0 g/dl
Kidney function
creatinine <1.5 x uln
Liver function
total bilirubin < 1.5 x uln; ast/alt < 2.5 x uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05385549 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require KIT?
Yes, KIT mutation is a required biomarker for enrollment.
Does this trial require PDGFRA?
Yes, PDGFRA mutation is a required biomarker for enrollment.
Are patients with PDGFRA alterations eligible?
No. PDGFRA D842V is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify