NCT07060014View on ClinicalTrials.gov

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

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

July 18, 2025

Primary Completion Date

September 30, 2026

Study Completion Date

December 31, 2026

Conditions
Advanced Small Intestine CancerAppendiceal Cancers
Interventions
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.

Trial Locations (1)

77030

Houston Methodist Hospital, Houston

All Listed Sponsors
lead

The Methodist Hospital Research Institute

OTHER