Study of NALIRIFOX Chemotherapy Before and After Surgery in Treating Patients With Resectable Pancreatic Adenocarcinoma A Randomized Phase II Trial Evaluating Perioperative and Adjuvant Treatment

What this Trial Is About

This research aims to evaluate the safety and activity of NALIRIFOX, a combination of liposomal irinotecan with fluorouracil, leucovorin, and oxaliplatin, for patients with resectable pancreatic adenocarcinoma. The study explores whether giving this treatment around the time of surgery perioperative is effective and safe compared to surgery followed by chemotherapy. Pancreatic cancer patients often face challenges completing chemotherapy after surgery, so this study also investigates whether giving chemotherapy before surgery helps control hidden cancer spread and improves surgical outcomes. Participants are randomly assigned to one of two groups. One group undergoes surgery first, followed by adjuvant chemotherapy with NALIRIFOX. The second group receives neoadjuvant chemotherapy with NALIRIFOX before surgery, then continues with adjuvant NALIRIFOX chemotherapy after the operation. This randomized Phase II trial compares these approaches to understand the best timing for delivering NALIRIFOX in this setting. During the study, participants will be closely monitored for treatment effects, surgery outcomes, and disease progression. Researchers will assess the 12-month event-free survival rate from enrollment to any event within a year. Participants will have scans such as CT or MRI to measure disease status, along with evaluations of organ function and overall health. The study includes safety monitoring, and participants will be followed from enrollment through treatment and recovery phases, lasting up to several years as needed.

Perioperative NALIRIFOX (liposomal Irinotecan in Combination with Fluorouracil, Leucovorin, and Oxaliplatin) in Resectable Pancreatic Adenocarcinoma: Randomized Phase II Trial