drugset / Trial / NCT05970900

Preoperative Imatinib Mesylate Combined With Rectal-sparing Surgery in Patients With c-KIT Gene-mutant Rectal GIST

NCT05970900

Phase 3 Not yet recruiting 23 enrolled Fujian Medical University Union Hospital
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

EvaluationDrugModalityDoseRoute
Subject Imatinib Small molecule 400 mg
Subject Imatinib Small molecule 600 mg
Subject Imatinib Small molecule 800 mg