Avapritinib Treatment for Unresectable or Recurrent Metastatic Gastrointestinal Stromal Tumors with Non-exon18 PDGFRA Mutations A Real-World Observational Study

What this Trial Is About

Researchers are exploring the use of Avapritinib therapy in patients with gastrointestinal stromal tumors GIST that have non-exon18 mutations of the PDGFRA gene. GISTs are common tumors in the gastrointestinal tract that vary from benign to malignant and often involve mutations in the KIT or PDGFRA genes. This study aims to understand the benefits of Avapritinib beyond the PDGFRA exon18 mutation and to investigate resistance mutations that affect treatment outcomes in advanced GISTs. This is a prospective, multicenter, observational real-world study focusing on patients with unresectable or recurrent metastatic GIST who have non-exon18 PDGFRA mutations and are treated with Avapritinib. Participants receive Avapritinib therapy as part of their routine care, and the study observes their responses and mutation changes over time. The study does not involve randomization or placebo groups but monitors participants under real-world conditions. Participants will undergo regular follow-up visits for clinical evaluation, imaging tests compliant with mRECIST v1.1 criteria, laboratory assessments, and recording of adverse events over two years. Researchers will measure outcomes such as objective response rate, clinical benefit rate, duration of response, progression-free survival, overall survival, and treatment-related safety events. The study emphasizes ongoing monitoring to provide evidence for personalized treatment approaches in advanced GIST patients.

Avapritinib in the Treatment of Unresectable or Recurrent Metastatic GIST Non-exon18 Mutations of PDGFRA