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Clinical trial · no report yet · Phase 3

NAPOLI 3

A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment

We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.

Commentary we found

Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.

ChannelFound
Podcasts11
YouTube5

The trial

ClinicalTrials.gov
Official title
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
Phase
Phase 3
Status
Completed
Conditions
Metastatic Adenocarcinoma of the Pancreas
Interventions
Irinotecan Liposomal Injection; Oxaliplatin; 5Fluorouracil; Leucovorin; Nab-paclitaxel; Gemcitabine
Arms
  • Irinotecan liposome injection + Oxaliplatin + 5-FU/LV · Experimental
  • Nab-paclitaxel + Gemcitabine · Active comparator
Enrollment
770
Primary outcomes
  • Overall Survival (OS)
Sponsor
Ipsen
Start
Feb 11, 2020
Primary completion
Jul 23, 2022
Results posted
Yes
Registry record
NCT04083235 · updated Apr 20, 2026

Publications

linked from the registry
  • Abdelrahim M, Khan G, Hatoum H, Zervoudakis A, Dayyani F, Zhang L, Li J, Maxwell F, O'Reilly EM, Wainberg ZA, Bullock A. Impact of UGT1A1*28 polymorphism in patients with metastatic pancreatic ductal adenocarcinoma treated with NALIRIFOX in the NAPOLI 3 trial. Future Oncol. 2026 May;22(12):1421-1428. doi: 10.1080/14796694.2026.2664776. Epub 2026 May 4. PubMed 42080361
  • Wainberg ZA, Melisi D, Macarulla T, Pazo Cid R, Chandana SR, De La Fouchardiere C, Dean A, Kiss I, Lee WJ, Goetze TO, Van Cutsem E, Paulson AS, Bekaii-Saab T, Pant S, Hubner RA, Xiao Z, Chen H, Benzaghou F, O'Reilly EM. NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised, open-label, phase 3 trial. Lancet. 2023 Oct 7;402(10409):1272-1281. doi: 10.1016/S0140-6736(23)01366-1. Epub 2023 Sep 11. PubMed 37708904