Actively Recruiting
Study of NALIRIFOX in Advanced Unresectable Small Bowel Tumors
Led by Tiago Biachi de Castria · Updated on 2026-02-17
36
Participants Needed
5
Research Sites
161 weeks
Total Duration
On this page
Sponsors
T
Tiago Biachi de Castria
Lead Sponsor
I
Ipsen
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of NALIRIFOX in Advanced Unresectable Small Bowel Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is at least 18 years old and has agreed to participate by signing informed consent.
- ECOG Performance Status of 0 or 1 within 28 days prior to registration and within 7 days before starting treatment.
- Histologically or cytologically confirmed small bowel adenocarcinoma not previously treated in the metastatic setting.
- Completed any prior adjuvant treatment more than 6 months ago with no significant residual toxicity.
- Disease is mismatch repair proficient or microsatellite stable.
- At least one metastatic lesion measurable by CT or MRI scan per RECIST 1.1 criteria.
- Adequate organ function based on blood tests within 28 days prior to registration and repeated within 7 days before treatment.
- Electrocardiogram without clinically significant findings and QTcF ≤450 msec.
- Negative pregnancy test for females of childbearing potential.
- Willingness to use effective contraception if sexually active and of childbearing potential.
- HIV-positive subjects may participate if stable on therapy and meeting specific criteria.
- Subjects with controlled hepatitis B or C infection meeting specific criteria may participate.
You will not qualify if you...
- Adenocarcinoma originating from ampulla or appendix.
- Neuroendocrine or other non-adenocarcinoma histology.
- Prior treatment with irinotecan.
- Prior metastatic treatment with surgery, radiotherapy, chemotherapy, or investigational therapy (except palliative radiotherapy with progression).
- Known central nervous system metastases unless stable and clinically assessed.
- Significant gastrointestinal disorders including severe diarrhea, malabsorption, inflammatory bowel disease, or partial bowel obstruction.
- Pregnant or breastfeeding women.
- History of other malignancies within the last 2 years except certain skin or in-situ cancers.
- Known allergies to study drugs or their components.
- Active cardiac or liver disease including recent severe arterial thromboembolic events or uncontrolled conditions.
- Active infection or unexplained fever above 38.5°C at screening or dosing day.
- Major surgery within 4 weeks prior to consent.
- Use of strong CYP3A, CYP2C8, or UGT1A1 inhibitors or inducers that cannot be discontinued.
- Contraindications per investigator brochure or drug prescribing information.
- Clinically unacceptable disease deterioration at screening.
- History of systemic connective tissue disorders.
- Receipt of live vaccine within 4 weeks prior to consent.
- History of certain lung diseases or peripheral artery disease.
- Known low or absent dihydropyridine dehydrogenase (DPD) activity where required by local regulations.
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
2
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612
Actively Recruiting
3
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
4
Atlantic Health System
Morristown, New Jersey, United States, 07960
Actively Recruiting
5
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
T
Tiago Biachi de Castria, MD, PhD
CONTACT
R
Rebecca Mottier
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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