NALIRIFOX (Nal-IRI Plus 5-FU/LV Plus Oxaliplatin) as First-Line Treatment for Patients With Advanced Small Intestine and Appendiceal Cancers
Recruiting · Phase 1 · NCT07060014
Conditions: Advanced Small Intestine Cancer, Appendiceal Cancers
At a glance
- Research payments reported, 2025
- $159,055
- U.S. investigators named
- 1
- Sites paid
- 1
- Planned or actual enrollment
- 22
About the trial
- Sponsor
- The Methodist Hospital Research Institute
- Tested
- 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 (drug)
- Dates
- Started 2026-09-18; completion 2029-12-31
- Results posted
- Not yet
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.
From ClinicalTrials.gov, last updated 2026-11-03. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Ipsen Biopharmaceuticals, Inc reported $159,055 in research payments for this study in 2025 (2 payments).
Products named: Onivyde
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- The Methodist Hospital Research $159,055
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.