A Study of the Safety and Activity of Liposomal Irinotecan in Combination With the 5-FU and Oxaliplatin in the Preoperative Treatment of Pancreatic Adenocarcinoma

Summary

This is a phase II, single arm, non-randomized, open label study of liposomal irinotecan with FOLFOX in the neoadjuvant setting in patients with resectable or borderline resectable, previously untreated pancreatic adenocarcinoma. The primary objective of this study is to investigate the safety and feasibility of this treatment regimen in this patient population.

Timeline

Start

2018-12-13

Primary completion

2023-09-16

Completion

2026-12

Outcome

Met primary endpoint

paper The 30-day post-operative major complication rate was 10% (95% CI, 2.2-27%, P = .012), meeting the pre-specified threshold. PMID 42371783 ↗

Publications

• George TJ, Lin T, Nassour I, Rogers SC, Jang T, Sahin I, Ramnaraign BH, Fabregas J, Hitchcock K, Liu G, Russell KB, Turk AA, Kayaleh O, Fan ZH, DeRemer DL, Thomas RM, Lee JH, Hughes SJ. Use of liposomal irinotecan with 5-FU and oxaliplatin (NALIRIFOX) in neoadjuvant pancreatic adenocarcinoma: NEO-Nal-IRI trial. Oncologist. 2026 Jun 29:oyag250. doi: 10.1093/oncolo/oyag250. Online ahead of print.
• Singhal R, Rogers SC, Lee JH, Ramnaraign B, Sahin I, Fabregas JC, Thomas RM, Hughes SJ, Nassour I, Hitchcock K, Russell K, Kayaleh O, Turk A, Zlotecki R, DeRemer DL, George TJ. A phase II study of neoadjuvant liposomal irinotecan with 5-FU and oxaliplatin (NALIRIFOX) in pancreatic adenocarcinoma. Future Oncol. 2023 Sep;19(27):1841-1851. doi: 10.2217/fon-2023-0256. Epub 2023 Sep 27.

Drugs

Indications