Perioperative NALIRIFOX (liposomal Irinotecan in Combination with Fluorouracil, Leucovorin, and Oxaliplatin) in Resectable Pancreatic Adenocarcinoma: Randomized Phase II Trial
Trial Parameters
Brief Summary
To explore the safety and activity of NALIRIFOX (liposomal irinotecan in combination with fluorouracil, leucovorin, and oxaliplatin) in the perioperative and adjuvant treatment in resectable pancreatic adeneocarcinoma.
Eligibility Criteria
Inclusion Criteria: * previously untreated, histologically or cytologically proven PDAC * age between 20 and 75 years at registration * ECOG performance status of 0 or 1 * AJCC (8th edition) clinical stage I or II with measurable disease (CT or MRI) in the pancreas. (positron emission tomography scan alone not allowed) * Surgically resectable disease according to NCCN criteria (Version 1.2023 - May 4, 2023): * no arterial tumor contact (celiac axis, superior mesentery artery, or common hepatic artery). * no tumor contact with the superior mesentery vein or portal vein or ≤180° contact without vein contour irregularity. * adequate major organ functions * Women of childbearing potential (including women with chemical menopause or no menstruation for other medical reasons) must agree to use contraception from the time ofinformed consent until 6 months or more after the last dose of investigational products. Also, women must agree not to breastfeed from the time of informed consent until 6