Trial reportThe oncologist2026
Use of liposomal irinotecan with 5-FU and oxaliplatin (NALIRIFOX) in neoadjuvant pancreatic adenocarcinoma: NEO-Nal-IRI trial.
Trial report in The oncologist, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03483038 (A Phase II, Open-label Pilot Study Evaluating the Safety and Activity of Liposomal Irinotecan in Combination With 5-FU and Oxaliplatin in Preoperative Treatment of Pancreatic Adenocarcinoma), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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A Phase II, Open-label Pilot Study Evaluating the Safety and Activity of Liposomal Irinotecan in Combination With 5-FU and Oxaliplatin in Preoperative Treatment of Pancreatic Adenocarcinoma (NEO-Nal- IRI Study)
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18 authors.
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Abstract
backgroundWhile neoadjuvant FOLFIRINOX is an effective regimen for pancreatic ductal adenocarcinoma (PDAC), toxicity frequently limits its use. Nanoliposomal irinotecan (nal-IRI) offers improved pharmacokinetic properties and may mitigate some of the side effects. We conducted a multi-institutional, phase II study to evaluate the safety and clinical activity of neoadjuvant NALIRIFOX (nal-IRI, 5-fluorouracil, leucovorin, and oxaliplatin) in patients with resectable and borderline resectable (R/BR) PDAC.
methodsPatients with untreated R/BR PDAC received 8 cycles of neoadjuvant NALIRIFOX. The primary endpoint was the 30-day post-operative major complication rate among resected patients. Secondary endpoints included treatment completion rate, R0 resection rate, objective response rate (ORR), biochemical (CA19-9) and radiographic responses, nodal downstaging, and quality of life (QoL by FACT-G).
resultsOf the 45 enrolled patients, 73% completed all 8 cycles of neoadjuvant NALIRIFOX. 34 patients (76%) underwent attempted surgery, of whom 29 (64%) had complete resection (15 BR patients and 14 R patients). The 30-day post-operative major complication rate was 10% (95% CI, 2.2-27%, P = .012), meeting the pre-specified threshold. R0 resection was achieved in 90% of resected patients. The radiographic ORR was 45% (95% CI, 29-62%), and the clinical benefit rate was 73% (95% CI, 58-85%).
conclusionNeoadjuvant NALIRIFOX is a safe and active regimen in R/BR PDAC with a low post-operative complication rate, high treatment completion and R0 resection rates, and meaningful clinical responses. These findings support further investigation of NALIRIFOX as part of a total neoadjuvant therapy approach in PDAC. [ClinicalTrials.gov identifier: NCT03483038].
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