Prospective Multicenter Clinical Study of Neoadjuvant Imatinib Mesylate for Gastrointestin
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 imatini
| Condition(s) | Progression-free Survival, Gastrointestinal Stromal Tumor, Neoadjuvant |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: * Preoperative histologically confirmed primary gastrointestinal stromal tumor * Tumor must stain positive for c-Kit (CD117) and/or discovered on gist-1 (DOG-1) by immunohistochemistry * Gene mutation test report including c-kit exons 9,11,13 and 17 and platelet-derived growth factor receptor alpha (PDGFRA) exons 12 and 18 * High risk GIST (as modified National Institutes of Health (NIH) 2008): stomach (maximum tumor diameter\> 10.0cm), nonstomach (maximum tumor diameter\> 5.0cm) * Gender is not limited. Age: ≥ 18 years and ≤ 80 years old * Performance status: Eastern Cooperative Oncology Group (ECOG) 0-1 * Patient had informed consent and signed a written consent form Exclusion Criteria: * Asp842Val (D842V) mutation in Exon 18 of PDGFRA gene, or wild type (c-kit exon 9 |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | First Affiliated Hospital of Zhejiang University |
| Locations | Hangzhou, Zhejiang, China |
| Start date | 2021-09-07 |
| NCT ID | NCT04933669 |
| Official listing | https://clinicaltrials.gov/study/NCT04933669 |