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Study of NALIRIFOX for Advanced Small Bowel Tumors

This study is looking into a treatment called NALIRIFOX for people with advanced small bowel adenocarcinoma (a type of cancer in the small intestine) that cannot be removed by surgery. The treatment involves a combination of four medicines given intravenously (into a vein): nanoliposomal irinotecan, oxaliplatin, 5-fluorouracil (5-FU), and leucovorin. You would receive these treatments on an outpatient basis. The study aims to see how many people respond to the treatment over three years. We are looking to enroll 36 participants, and the current recruitment status is unclear. You must be at least 18 years old to participate.

Study design
This is an interventional study with a planned enrollment of 36 participants. The phase of the study is not specified.
What's involved
You will receive treatment on Day 1 and Day 15 of each 28-day cycle, with some medications given over several hours. You may go home with an infusion pump for 5-FU and will continue treatment until the cancer progresses, side effects are too severe, or you choose to stop.
Compensation
Not stated in the trial record.
Follow-up
The primary goal of the study, Objective Response Rate, will be measured at 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06835387

Study of NALIRIFOX in Advanced Unresectable Small Bowel Tumors

Recruiting
PHASE2Ages 18+InterventionalTreatment
Tiago Biachi de Castria
~36 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:Nanoliposomal irinotecanOxaliplatin5 fluorouracilLeucovorin

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate (ORR)
Measured over 3 years

Conditions

Small Bowel Adenocarcinoma

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NCT06835387

Where you'd take part

This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Atlantic Health System

    Morristown, New Jerseystudy coordinator listed

    Recruiting

  • Moffitt Cancer Center

    Tampa, Floridastudy coordinator listed

    Recruiting

  • Parkview Research Center

    Fort Wayne, Indianastudy coordinator listed

    Recruiting

  • University of Illinois Cancer Center

    Chicago, Illinoisstudy coordinator listed

    Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texasstudy coordinator listed

    Recruiting

  • Virginia Commonwealth University

    Richmond, Virginiastudy coordinator listed

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouristudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Tiago Biachi de Castria, MD, PhD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center

Who to contact

Tiago Biachi de Castria, MD, PhD
[email protected]
8137452559
Email the study team

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Eligibility criteria

Inclusion

Platelets (Plt) ≥ 100,000 cells/mm3
Absolute Neutrophil Count (ANC) ≥ 1,500 cells/mm3; without the use of hemopoietic growth factors
Hemoglobin (Hgb) ≥ 9 g/dL
Calculated creatinine clearance ≥ 30 mL/min; Cockcroft-Gault formula for actual body weight should be used for calculation. For subjects with a body mass index (BMI) \> 30 kg/m2, adjusted body weight should be used instead
Total bilirubin ≤ 1.5 × ULN
Aspartate aminotransferase (AST) ≤ 2 × ULN; \< 5× with liver metastases
Alanine aminotransferase (ALT) ≤ 2 × ULN; \< 5× with liver metastases
Albumin ≥ 2.5 gm/dL
PT/INR and aPTT ≤ 1.5 x ULN; subjects on warfarin or other vitamin K antagonists should be discussed with the sponsor-investigator.
Urinalysis: Urinalysis results without clinically significant abnormalities, per the investigator's assessment 8. Subjects treated in the adjuvant setting who completed treatment \> 6 months prior to registration and do not have residual toxicities \> Grade 1 are eligible. 9. Electrocardiogram (ECG) without any clinically significant findings (QT interval corrected by Fridericia's formula (QTcF) ≤450 msec and no known arrhythmias) and per the investigator's assessment. 10. Females of childbearing potential must have a negative urine or serum pregnancy test within ≤ 7 days prior to registration. If a urine test is done and it is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 11. Females of childbearing potential who are sexually active with a male able to father a child must be willing to abstain from penile-vaginal intercourse or use an effective method(s) of contraception. Males able to father a child who are sexually active with a female of childbearing potential must be willing to abstain from penile-vaginal intercourse or use an effective method(s) of contraception. 12. Subjects with known human immunodeficiency virus (HIV) are eligible if they meet all the following criteria:
CD4 count is ≥350 cells/uL, viral load is undetectable, and not taking prohibited cytochrome (CYP)-interacting medications;
Probable long-term survival with HIV if cancer were not present;
Stable on a highly active antiretroviral therapy (HAART) regimen for ≥ 4 weeks and willing to adhere to their HAART regimen with minimal overlapping toxicity and drug-drug interactions with the experimental agents in this study;
HIV is not multi-drug resistant;
Taking medication and/or receiving antiretroviral therapy that does not interact or have overlapping toxicities with the study medication.
Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) less than 6 months before registration
High cardiovascular risk, including, but not limited to, recent coronary stenting or myocardial infarction in the past year prior to registration
New York Heart Association (NYHA) Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure 11. Active infection or an unexplained fever \>38.5°C during screening visits or on the first scheduled day of dosing (at the discretion of the investigator, subjects with tumor fever may be enrolled), which in the investigator's opinion might compromise the subject's participation in the study or affect the study outcome. 12. Major surgery, other than diagnostic surgery, within 4 weeks prior to registration. 13. Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1. Subjects are ineligible if:
they are unable to discontinue the use of strong inhibitors of CYP3A, CYP2C8 and UGT1A1 at least 1 week prior to registration;
they are unable to discontinue the use of strong CYP3A and CYP2C8 inducers at least 2 weeks prior to registration; 14. There is presence of any contraindications outlined in the Contraindications or Warnings and Precautions sections of the IB for nanoliposomal irinotecan, or in the prescribing information for 5-FU, LV or oxaliplatin. 15. Subjects who, in the opinion of the investigator, have symptoms or signs suggestive of clinically unacceptable deterioration of the primary disease at the time of screening. 16. History of systemic connective tissue disorders (e.g. lupus, scleroderma, arteritis nodosa). 17. Subjects who have received a live vaccine within 4 weeks prior to registration. 18. History of the following: interstitial lung disease, slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies, and peripheral artery disease (e.g. claudication, Leo Buerger's disease). 19. Known complete (poor metabolizer) DPD/DYPD deficiency. Pre-treatment testing for DPYD variants (genotyping) is strongly recomended (or required by local regulations) prior to initiating fluoropyrimidines. Pre-treatment UGT1A1 genotyping may also be considered.

Exclusion

Palliative radiotherapy is permitted but lesions in a prior radiation field must have progressed subsequent to radiotherapy to be considered measurable.
Placement of biliary stent/tube is permitted.
Palliative surgery (for example to treat obstruction)

What this trial measures

  • Objective Response Rate (ORR)3 years

    ORR is defined as the proportion of subjects with a confirmed complete or partial response to treatment according to RECIST 1.1, by local assessment.