Condition: Small Bowel Adenocarcinoma · Sponsor: Tiago Biachi de Castria
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.
This description comes directly from the study's public registry record.
Tiago Biachi de Castria, MD, PhD · 8137452559 · tiago.biachi@moffitt.org
LeaEtta Hyer · 3176345842 · lhyer@hoosiercancer.org
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| Atlantic Health System | Morristown, New Jersey, United States | Recruiting |
| University of Texas Southwestern Medical Center | Dallas, Texas, United States | Recruiting |
| Virginia Commonwealth University | Richmond, Virginia, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06835387