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Advanced Small Intestine CancerPhase 1NCT07060014

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

A Phase 1 study testing 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 in people with Advanced Small Intestine Cancer and Appendiceal Cancers, run by The Methodist Hospital Research Institute at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study will evaluate the safety and efficacy of NALIRIFOX per NAPOLI-3 regimen as first-line chemotherapy for patients with advanced small intestine and appendiceal cancers. Female or male patients aged 18 years, or older, with histopathologically or cytologically confirmed advanced mucinous or non-mucinous… Read more about this study

Who is it for?
Ages 18 years and older
What is being 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
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
2 sitesUnited States
Study dates
18 Sep 2026to 31 Dec 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female ≥18 years of age.
  • Histopathologically or cytologically confirmed advanced mucinous or non-mucinous appendix cancer or advanced small intestine cancer.
  • Measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  • Eastern Cooperative Oncology Group performance status of 0 or 1.
  • Life expectancy ≥6 months.
  • Patients of childbearing potential must agree to use an adequate method of contraception during the study and for 30 days after the last dose of study treatment.

Who cannot join

  • 1. Hematology laboratory values of:
  • Absolute neutrophil count ≤1500 cells/mm3
  • Platelets ≤100,000 cells/mm3
  • Hemoglobin ≤9 g/dL
  • White blood count ≤3000 cells/mm3. 2. Hepatic laboratory values of aspartate transaminase or alanine aminotransferase:
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  • >5 × upper limits of normal (ULN) if the documented history of hepatic metastases; or
  • >2.5 × ULN if no liver metastases are present. 3. Total bilirubin >1.5 × ULN or >1.5 mg/dL. 4. Prothrombin time (PT) or international normalized ratio (INR) >1.5 × ULN. Note: Patients receiving therapeutic doses of anticoagulant therapy may be considered eligible if PT and INR are within the acceptable institutional therapeutic limits.
  • 5. Serum creatinine or serum urea >1.5 × ULN. 6. Estimated glomerular filtration rate <50 mL/min. 7. Positive pregnancy test, pregnancy, or breastfeeding (female patients only). 8. Any other clinically significant laboratory abnormality that would compromise patient safety or the outcome of the study.
  • 9. Any clinically significant and/or uncontrolled cardiac-related abnormality that would compromise patient safety or the outcome of the study including, but not limited to:
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  • Arrhythmia
  • Bradycardia
  • Tachycardia
  • Symptomatic valvular disease
  • Symptomatic congestive heart failure is classified by the New York Heart Association as Class III or IV
  • Unstable angina pectoris. 10. Myocardial infarction within the past 6 months. 11. Active bleeding diathesis. 12. Current complaints of persistent constipation or history of chronic constipation, bowel obstruction, or fecaloma within the past 6 months.
  • 13. Receiving chronic treatment with corticosteroids ≥5 mg of prednisone per day (or equivalent) or another immunosuppressive agent (s) 14. Known history and/or uncontrolled hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV)-1 or HIV-2.
  • 15. History of galactose intolerance, deficiency of Lapp lactase, or glucose-galactose malabsorption.
  • 16. History of malignancy or active treatment for malignancy (i.e., radiation or chemotherapy, including monoclonal antibodies) within 5 years. Note: Patients with squamous or basal cell carcinomas of the skin, carcinomas in situ of the cervix or uterus, ductal breast cancer in situ, resected low-grade prostate cancer, or other malignancies that in the opinion of the investigator are considered cured may participate.
  • 17. Receipt of live, attenuated vaccine (e.g., intranasal influenza, measles, mumps, rubella, varicella) or close contact with someone who has received a live, attenuated vaccine within the past 1 month. Note: Influenza vaccine will be allowed if administered >21 days.
  • 18. Receipt of any investigational agent or study treatment within the past 30 days.
  • 19. Receipt of any protein or antibody-based therapeutic agents (e.g., growth hormones or monoclonal antibodies) within the past 3 months.
  • 20. Allergies reaction to irinotecan or liposomal irinotecan.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Maen Abdelrahim, MD,PhD contact

713-441-1240

mabdelrahim@houstonmethodist.org

Abdullah Esmail, MD contact

AEsmail@houstonmethodist.org

United States2 sites, 2 recruiting

  • Cockrell Center for Advanced Therapeutics 6565 Fannin M604

    Houston, Texas, 77030

    Jennifer Garrett,, MSN, RN, CCRP, 3462327383, AEsmail@houstonmethodist.org

    Recruiting

  • Houston Methodist Hospital

    Houston, Texas, 77030

    Jennifer Garrett, RN, 346-238-4516, jmgarrett@houstonmethodist.org

    Abdullah Esmail, MD, aesmail@houstonmethodist.org

    Not yet recruiting

Other trials in United States

About this study

Official title: Liposomal Irinotecan (Nal-IRI) Plus 5-fluorouracil and Leucovorin (5-FU/LV) Plus Oxaliplatin (NALIRIFOX) as First-Line Chemotherapy for Patients With Advanced Small Intestine and Appendiceal Cancers

This study will evaluate the safety and efficacy of NALIRIFOX per NAPOLI-3 regimen as first-line chemotherapy for patients with advanced small intestine and appendiceal cancers. Female or male patients aged 18 years, or older, with histopathologically or cytologically confirmed advanced mucinous or non-mucinous appendix cancer or advanced small intestine cancer will be eligible for participation in the study.

Read the detailed description

This study will evaluate the safety and efficacy of NALIRIFOX per NAPOLI-3 regimen as first-line chemotherapy for patients with advanced small intestine and appendiceal cancers. Female or male patients aged 18 years, or older, with histopathologically or cytologically confirmed advanced mucinous or non-mucinous appendix cancer or advanced small intestine cancer will be eligible for participation in the study. Approximately, 22 patients will be enrolled in the study. The study drugs will be administered per the regimen defined in the NAPOLI-3 clinical trial, NCT04083235. Patients will be treated with NALIRIFOX (liposomal irinotecan 50 mg/m2 + 5-FU 2400 mg/m2 + LV 400 mg/m2 + oxaliplatin 60 mg/m2) every 2 weeks for 12 months.

Being 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
Keywords
Advanced Small Intestine cancer, Appendiceal Cancers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 monthsDrug

    The study drugs will be administered per the regimen defined in the NAPOLI-3 clinical trial. 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.

Study groups in NCT07060014
Study groupRoleWhat they receive
nal-IRI plus 5-FU/LV plus NALIRIFOXExperimentalPatients in this arm will receive NALIRIFOX
Receives: Drug: 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
Historical Control ArmNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    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.

    Measured: Over 12 months

Secondary outcomes (1)

  1. Duration of response to Nalirifox per Napoli-3 regimen as first-line chemotherapy in patients with advanced non-resectable small intestine and appendiceal cancers, assessed by RECIST v1.1

    This measure evaluates the duration of response to Nalirifox per Napoli-3 regimen, defined as the time from the first documented objective response (complete response or partial response) per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 until disease progression or death, whichever occurs first. Data will be collected through radiographic assessments (e.g., CT or MRI scans) at regular intervals and summarized as the median duration of response in months.

    Measured: Over 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2025
  2. Study start18 Sep 2026
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07060014
Sponsor's protocol ID
PRO00038285
Status last verified
Nov 2026
First submitted
10 Jun 2025
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 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 in people with Advanced Small Intestine Cancer and Appendiceal Cancers, run by The Methodist Hospital Research Institute at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maen Abdelrahim, MD,PhD (713-441-1240, mabdelrahim@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Over 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07060014.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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