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An Open-label, Randomised, Multicentre, Phase III Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Leucovorin Versus Nab-paclitaxel Plus Gemcitabine in Subjects Who Have Not Previously Received Chemotherapy for Metastatic Adenocarcinoma of the Pancreas

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Trial Profile

An Open-label, Randomised, Multicentre, Phase III Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Leucovorin Versus Nab-paclitaxel Plus Gemcitabine in Subjects Who Have Not Previously Received Chemotherapy for Metastatic Adenocarcinoma of the Pancreas

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 May 2025

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At a glance

  • Drugs Fluorouracil (Primary) ; Folic acid (Primary) ; Irinotecan (Primary) ; Oxaliplatin (Primary) ; Gemcitabine; Paclitaxel
  • Indications Adenocarcinoma; Pancreatic cancer; Pancreatic ductal carcinoma
  • Focus Registrational; Therapeutic Use
  • Acronyms NAPOLI 3
  • Sponsors Ipsen

Most Recent Events

  • 17 Apr 2025 Results assessing Cost-effectiveness of NALIRIFOX versus Nab-paclitaxel and gemcitabine in previously untreated metastatic pancreatic ductal adenocarcinoma, published in the BMC Gastroenterology.
  • 04 Jun 2024 Results of updated analysis of OS, presented at the 60th Annual Meeting of the American Society of Clinical Oncology
  • 29 May 2024 According to a Florida Cancer Specialists & Research Institute media release, data from this study will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

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