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

Summary

The purpose of this study is to look at the efficacy and safety of Irinotecan liposome injection in combination with other approved drugs used for cancer therapy, namely 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to nab-paclitaxel + gemcitabine treatment in improving the overall survival of patients not previously treated for metastatic pancreatic cancer.

Timeline

Start

2020-02-11

Primary completion

2022-07-23

Completion

2025-02-18

Outcome

Met primary endpoint

registry analysis (other test); NALIRIFOX vs Nab-paclitaxel+Gemcitabine; p = 0.04; Hazard Ratio (HR) 0.83 (95% CI 0.70 to 0.99); Stratified log-rank test NCT04083235 ↗

Publications

• 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.
• 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.

Drugs

Indications