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

ClinicalTrials.gov ID: NCT07060014

Public ClinicalTrials.gov record NCT07060014. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 10, 2026, 9:35 PM EDT

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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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT07060014
Recruitment status: Not yet recruiting
Study type: Interventional
Phase: Phase 1
Lead sponsor: The Methodist Hospital Research Institute; Other
Enrollment: 22 participants

Conditions and interventions

Conditions

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

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jul 17, 2025
Primary completion: Sep 29, 2026
Completion: Dec 30, 2026
Last update posted: Jul 10, 2025

2025 – 2026

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Houston Methodist Hospital	Houston	Texas	77030	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07060014, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jul 10, 2025 · Synced Sep 10, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07060014 live on ClinicalTrials.gov.

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