drugset / Trial / NCT07060014

NALIRIFOX (Nal-IRI Plus 5-FU/LV Plus Oxaliplatin) as First-Line Treatment for Patients With Advanced Small Intestine and Appendiceal Cancers

NCT07060014

Phase 1 Not yet recruiting 22 enrolled The Methodist Hospital Research Institute
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study will evaluate the safety and efficacy of NALIRIFOX per NAPOLI-3 regimen as first-line chemotherapy for patients with advanced small intestine and appendiceal cancers. Female or male patients aged 18 years, or older, with histopathologically or cytologically confirmed advanced mucinous or non-mucinous appendix cancer or advanced small intestine cancer will be eligible for participation in the study.

Timeline

Start
2025-07-18
Primary completion
2026-09-30
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 50 mg/m2 Intravenous
Subject Leucovorin Small molecule 400 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 60 mg/m2 Intravenous
Subject fluorouracil Small molecule 2400 mg/m2 Intravenous