OncoMatch/Clinical Trials/NCT04933669
Prospective Multicenter Clinical Study of Neoadjuvant Imatinib Mesylate for Gastrointestinal Stromal Tumors
Is NCT04933669 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
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)
Demographics
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.
Frequently asked questions
Is NCT04933669 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require KIT?
Yes, KIT immunohistochemistry positive is a required biomarker for enrollment.
Does this trial require ANO1?
Yes, ANO1 immunohistochemistry positive is a required biomarker for enrollment.
Are patients with PDGFRA alterations eligible?
No. PDGFRA D842V is an exclusion criterion.
Are patients with KIT alterations eligible?
No. KIT exon 9 is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 80 years or younger.
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 qualifyRelated pages