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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Sep 30, 2026 → Sep 30, 2028
See other at-risk trials from The Methodist Hospital Research Institute

Record History

  1. Primary completion pushed from Sep 30, 2026 to Sep 30, 2028 Recruitment opened · Start date: Jul 18, 2025 to Sep 18, 2026 · Completion pushed from Dec 31, 2026 to Dec 31, 2029 · 4 more Show 7 more changesShow less
    • Recruitment opened
    • Start date: Jul 18, 2025 to Sep 18, 2026
    • Completion pushed from Dec 31, 2026 to Dec 31, 2029
    • Study sites: 1 to 2
    • 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… to 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…
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 1 of 1 entry
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07060014
Lead Sponsor The Methodist Hospital Research Institute
Conditions Advanced Small Intestine Cancer, Appendiceal Cancers
Enrollment 22 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov