Not Yet RecruitingPhase 1

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

United States22 participantsStarted 2025-07-18

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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:
✕. \>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.

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

Timeframe: Over 12 months

Trial details

NCT IDNCT07060014

SponsorThe Methodist Hospital Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Maen Abdelrahim, MD,PhD

713-441-1240 mabdelrahim@houstonmethodist.org

View on ClinicalTrials.gov More Advanced Small Intestine Cancer trials