drugset / Trial / NCT05970900
Preoperative Imatinib Mesylate Combined With Rectal-sparing Surgery in Patients With c-KIT Gene-mutant Rectal GIST
NaSingle-groupOpen-labelTreatment
Summary
Prior to the implementation of preoperative imatinib mesylate therapy, a considerable percentage (ranging from 34.5% to 67.5%) of individuals diagnosed with rectal gastrointestinal stromal tumors (GIST) underwent abdominoperineal resection (APR), a surgical procedure that involved the removal of the anus and necessitated a permanent colostomy. This study aims to investigate the safety and viability of an organ-preserving approach involving preoperative imatinib mesylate treatment in conjunction with local resection for rectal GIST, specifically targeting patients with c-KIT gene mutations.
Timeline
- Start
- 2023-10-01
- Primary completion
- 2026-10-01
- Completion
- 2029-10-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Imatinib | Small molecule | 400 mg | — |
| Subject | Imatinib | Small molecule | 600 mg | — |
| Subject | Imatinib | Small molecule | 800 mg | — |