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

Conditions

• Advanced Small Intestine Cancer
• Appendiceal Cancers

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

Start date

Jul 18, 2025

Status verified

Jun 2025

Primary completion

Sep 30, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

22 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: nal-IRI plus 5-FU/LV plus NALIRIFOX
  Patients in this arm will receive NALIRIFOX
• No Intervention: Historical Control Arm

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 ]

Central Contacts

• Maen Abdelrahim, MD,PhD
  713-441-1240
  [email protected]
• Abdullah Esmail, MD
  [email protected]

Locations (1)

Find similar trials in Houston, TX