Study of NALIRIFOX in Advanced Unresectable Small Bowel Tumors

About the trial

Sponsor

Tiago Biachi de Castria (with Ipsen, H. Lee Moffitt Cancer Center and Research Institute)

Tested

Nanoliposomal irinotecan (drug), Oxaliplatin (drug), 5 fluorouracil (drug), Leucovorin (drug)

Dates

Started 2025-06-30; completion 2028-08

Results posted

Not yet

The study regimen will be administered on an outpatient basis and all medications are administered intravenously (IV). Subjects will receive treatment on Day 1 and Day 15 of each 28-day cycle consisting of the following: nanoliposomal irinotecan at 50 mg/m2, followed by oxaliplatin 60 mg/m2, followed by leucovorin at 400 mg/m2 30 minutes after completion of oxaliplatin, followed by 5-FU 2400 mg/m2 60 minutes after leucovorin completion. Subjects will receive up to 6 cycles of NALIRIFOX then based on response and per physician discretion, de-escalated maintenance treatment with NALIRIFOX minus oxaliplatin may continue. Subjects will continue de-escalated maintenance treatment until progres…

From ClinicalTrials.gov, last updated 2026-07-28. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Ipsen Biopharmaceuticals, Inc reported $1.5M in research payments for this study in 2025 (13 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.