Study of NALIRIFOX in Advanced Unresectable Small Bowel Tumors

Conditions

• Small Bowel Adenocarcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Nanoliposomal irinotecan — DRUG
  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).
• Oxaliplatin — DRUG
  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.
• 5 fluorouracil — DRUG
  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).
• Leucovorin — DRUG
  Leucovorin 400 mg/m2 will be administered over 30 minutes IV.

Study Details

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.

Key Dates

Start date

Jun 30, 2025

Status verified

Jun 2026

Primary completion

Aug 31, 2027

Completion

Aug 31, 2028

Study Design

Enrollment

36 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: NALIRIFOX and De-escalated maintenance
  Cycle 1 to Cycle 6: NALIRIFOX 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. Patients will receive up to 6 cycles of NALIRIFOX. Cycle 7+: De-escalated Maintenance: Based on response to Cycles 1-6 and per physician discretion, de-escalated maintenance treatment with NALIRIFOX minus oxaliplatin may continue as de-escalated maintenance treatment until progression per RECIST 1.1, intolerable toxicity or physician/subject choice to discontinue.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: 3 years ]

Central Contacts

• Tiago Biachi de Castria, MD, PhD
  8137452559
  [email protected]
• LeaEtta Hyer
  3176345842
  [email protected]

Locations (6)

Find similar trials in Tampa, FL

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