Phase 2 NALIRIFOX trial: liposomal irinotecan (topoisomerase I inhibitor) for advanced small intestine/appendiceal cancers

This trial assesses the safety and efficacy of first-line chemotherapy in advanced disease. The study uses an expansion arm receiving investigational NALIRIFOX regimen with nal-IRI (liposomal topoisomerase I inhibitor), 5-FU (thymidylate synthase inhibitor), leucovorin (5-FU modulator) and oxaliplatin (DNA synthesis inhibitor) compared with a historical observational arm. Eligible participants are adults with advanced small intestine or appendiceal cancer, aiming to establish first-line safety and efficacy under The Methodist Hospital Research Institute sponsorship.