Study of Sunitinib and Regorafenib Guided by KIT Gene Mutations for Treating Gastrointestinal Stromal Tumors

What this Trial Is About

Researchers are investigating whether specific mutations in the KIT gene, particularly in exons 13 and 17, can predict how patients with gastrointestinal stromal tumors GIST respond to standard treatments. This Phase 2 study focuses on patients who have metastatic or unresectable GIST and have had prior treatments including imatinib. The goal is to understand how these genetic changes affect treatment outcomes with Sunitinib or Regorafenib. Participants are grouped based on their KIT gene mutation those with exon 13 mutations receive Sunitinib orally once daily in 28-day cycles, while those with exon 17 mutations receive Regorafenib orally with a schedule of three weeks on treatment followed by one week off. If disease progresses on the initial therapy, patients may switch to the other drug. Treatment lasts for up to 12 months. During the study, researchers will monitor how many participants achieve an overall response to treatment and assess progression-free and overall survival over up to three years. They will also track clinical benefits, side effects, and treatment-related toxicities. Patients will have regular visits for assessments including blood tests to detect mutations, safety evaluations, and monitoring of treatment effects throughout the study period.

ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST