RecruitingPhase 2NCT06835387

Study of NALIRIFOX in Advanced Unresectable Small Bowel Tumors

Phase II Study of NALIRIFOX (Nanoliposomal Irinotecan + Oxaliplatin With Fluorouracil and Folinic Acid) in Advanced Unresectable Small Bowel Tumors

Sponsor

Tiago Biachi de Castria

Enrollment

36 participants

Start Date

Jun 30, 2025

Study Type

INTERVENTIONAL

Conditions

Small-bowel Adenocarcinoma

Summary

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 progression per RECIST 1.1, intolerable toxicity or physician/subject choice to discontinue.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 5 fluorouracil, a drug called Leucovorin, and others for people with small-bowel adenocarcinoma. The study is currently recruiting participants at 7 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGNanoliposomal irinotecan

Nanoliposomal Irinotecan 50 mg/m2 will be administered over 90 minutes (± 10 minutes) IV. All subjects must be pre-medicated prior to nanoliposomal irinotecan infusion with standard doses of dexamethasone and a 5-HT3 antagonist, or equivalent other anti-emetics (according to standard institutional practices).

DRUGOxaliplatin

Oxaliplatin 60 mg/m2 will be administered over 120 minutes (± 10 minutes) IV. Institutional standards may be used for all aspects of oxaliplatin administration including premedication administration.

DRUG5 fluorouracil

5-FU will be administered as a continuous infusion over 46 hours. Subjects will go home with an infusion pump and return to clinic at the end of infusion for removal of the pump or, if possible, the pump may be removed at the subject's home (except on Cycle 1 Day 3).

DRUGLeucovorin

Leucovorin 400 mg/m2 will be administered over 30 minutes IV.