OncoMatch/Clinical Trials/NCT04933669
Prospective Multicenter Clinical Study of Neoadjuvant Imatinib Mesylate for Gastrointestinal Stromal Tumors
Is NCT04933669 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Imatinib for progression-free survival.
Treatment: Imatinib — The R0 resection rate of gastrointestinal stromal tumor (GIST) with high recurrence risk was relatively low, and the relapse-free survival rate was relatively low, which needed to be further improved. A few retrospective analyses and a small sample of prospective studies have found that neoadjuvant therapy with imatinib mesylate can improve R0 resection rates. Whether neoadjuvant therapy prolongs long-term survival remains unclear. The primary objective of this study was to evaluate 5-year progression-free survival (PFS) for GIST patients with high recurrence risk after neoadjuvant treatment with imatinib mesylate.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastrointestinal Stromal Tumor
Biomarker criteria
Required: KIT immunohistochemistry positive (positive)
Tumor must stain positive for c-Kit (CD117)
Required: ANO1 immunohistochemistry positive (positive)
Tumor must stain positive for...gist-1 (DOG-1) by immunohistochemistry
Excluded: PDGFRA D842V
Asp842Val (D842V) mutation in Exon 18 of PDGFRA gene
Excluded: KIT exon 9
c-kit exon 9 mutation
Excluded: KIT wild-type
wild type (c-kit exon 9,11,13,17, and PDGFRA Exon 12,18)
Excluded: PDGFRA wild-type
wild type (c-kit exon 9,11,13,17, and PDGFRA Exon 12,18)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: tyrosine kinase inhibitor (imatinib)
Treated with tyrosine kinase inhibitors including Imatinib
Lab requirements
Blood counts
ANC < 1.5 × 10^9 / L; Platelet count (PLT) < 75 × 10^9 / L; Hemoglobin (Hb) ≥ 90 g / L
Kidney function
Creatinine (Cr) >1.0×ULN [excluded]
Liver function
AST and/or ALT >2.5×ULN, or TBIL >1.5×ULN [excluded]
AST and/or ALT >2.5×ULN(upper limit of normal)，or Total bilirubin (TBIL)>1.5×ULN，or Creatinine (Cr)>1.0×ULN; ANC < 1.5 × 10^9 / L；or Platelet count (PLT) < 75 × 10^9 / L；or Hemoglobin (Hb) ≥ 90 g / L
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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