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

NCT07060014 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: PRO00038285
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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 appendix cancer or advanced small intestine cancer will be eligible for participation in the study.

Conditions

Advanced Small Intestine Cancer; Appendiceal Cancers

Keywords

Advanced Small Intestine cancer; Appendiceal Cancers

Outcome Measures

Primary Outcomes (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.

  Over 12 months

Secondary Outcomes (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

  Over 12 months

Study Arms (2)

nal-IRI plus 5-FU/LV plus NALIRIFOX

EXPERIMENTAL

Patients in this arm will receive NALIRIFOX

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 Arm

NO INTERVENTION

Interventions

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 DRUG

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.

nal-IRI plus 5-FU/LV plus NALIRIFOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.
• \. 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.
• \. 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

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

irinotecan sucrosofate; Fluorouracil; Oxaliplatin

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals

Study Officials

• Abdullah Esmail, MD

  Houston Methodist Nael Cancer Center

  STUDY DIRECTOR

Central Study Contacts

Maen Abdelrahim, MD,PhD

CONTACT

713-441-1240; mabdelrahim@houstonmethodist.org

Abdullah Esmail, MD

CONTACT

AEsmail@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Gastrointestinal Medical Oncology

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: July 11, 2025
• Study Start: July 18, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)