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NALIRIFOX for Advanced Small Intestine and Appendiceal Cancers

This study is testing a treatment called NALIRIFOX (liposomal irinotecan, 5-FU, LV, and oxaliplatin) for people with advanced small intestine or appendiceal cancers. NALIRIFOX is a combination of chemotherapy drugs. The main goal is to see how safe this treatment is by tracking any side effects over 12 months. You may be able to join if you are 18 or older, have confirmed advanced small intestine or appendiceal cancer that can be measured, and meet other health criteria. The study plans to enroll about 22 participants. The current status of the study is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll about 22 participants.
What's involved
Participants will receive NALIRIFOX intravenously (through a vein) every two weeks for 12 months.
Compensation
Not stated in the trial record.
Follow-up
The study will assess treatment-related side effects over 12 months.

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NCT07060014

NALIRIFOX (Nal-IRI Plus 5-FU/LV Plus Oxaliplatin) as First-Line Treatment for Patients With Advanced Small Intestine and Appendiceal Cancers

Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatment
The Methodist Hospital Research Institute
~22 participants
Updated 2025-07-11 on ClinicalTrials.gov
What's tested:Patients will be treated with NALIRIFOX (liposomal irinotecan 50 mg/m2 + 5-FU 2400 mg/m2 + LV 400 mg/m2 + oxaliplatin 60 mg/m2, IV) every 2 weeks for 12 months

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 in patients receiving Nalirifox per Napoli-3 regimen as first-line chemotherapy for advanced non-resectable small intestine and appendiceal cancers
Measured over Over 12 months

Conditions

Advanced Small Intestine Cancer
Appendiceal Cancers

Explore related trials

Appendix CarcinomaSmall Intestinal Carcinoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Abdullah Esmail, MD · STUDY_DIRECTOR · Houston Methodist Nael Cancer Center

Who to contact

Maen Abdelrahim, MD,PhD
[email protected]
713-441-1240
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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

1\. Hematology laboratory values of:

What this trial measures

  • Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 in patients receiving Nalirifox per Napoli-3 regimen as first-line chemotherapy for advanced non-resectable small intestine and appendiceal cancersOver 12 months

    This measure evaluates the safety and tolerability of Nalirifox per Napoli-3 regimen by reporting the number of participants experiencing treatment-related adverse events, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Data will be collected through clinical assessments, including physical examinations, laboratory tests, and patient-reported adverse events, and summarized as the total count and severity of events per participant.