NCT07060014

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Approximately, 22 patients will be enrolled in the study. The study drugs will be administered per the regimen defined in the NAPOLI-3 clinical trial, NCT04083235. Patients will be treated with NALIRIFOX (liposomal irinotecan 50 mg/m2 + 5-FU 2400 mg/m2 + LV 400 mg/m2 + oxaliplatin 60 mg/m2) every 2 weeks for 12 months.

Conditions

• Advanced Small Intestine Cancer
• Appendiceal Cancers

Interventions

Type	Name	Description
DRUG	Patients will be treated with NALIRIFOX (liposomal irinotecan 50 mg/m2 + 5-FU 2400 mg/m2 + LV 400 mg/m2 + oxaliplatin 60 mg/m2, IV) every 2 weeks for 12 months	The study drugs will be administered per the regimen defined in the NAPOLI-3 clinical trial. Patients will be treated with NALIRIFOX (liposomal irinotecan 50 mg/m2 + 5-FU 2400 mg/m2 + LV 400 mg/m2 + oxaliplatin 60 mg/m2, IV) every 2 weeks for 12 months.

Timeline

• Start date: 2025-07-18
• Primary completion: 2026-09-30
• Completion: 2026-12-31
• First posted: 2025-07-11
• Last updated: 2025-07-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study