Phase 2 Study Comparing NALIRIFOX and Modified Gemcitabine, Nab-Paclitaxel, and Cisplatin in Untreated Patients With Locally Advanced or Metastatic Pancreatic Cancer

What this Trial Is About

Researchers are evaluating two chemotherapy treatments, NALIRIFOX and a modified combination of gemcitabine, nab-paclitaxel, and cisplatin mGAP, in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma PDAC who have not received prior treatment. This Phase 2 trial aims to compare the effectiveness of these regimens in improving clinical outcomes for this serious cancer, which remains a leading cause of cancer-related deaths with a poor prognosis. The study involves two treatment groups one receiving NALIRIFOX, which includes liposomal irinotecan, oxaliplatin, 5-fluorouracil, and leucovorin administered every two weeks, and the other receiving mGAP, with gemcitabine, nab-paclitaxel, and cisplatin given on Day 1 and Day 15 of a 28-day cycle. The trial investigates whether mGAP can achieve a higher overall response rate with manageable toxicity compared to NALIRIFOX. Participants will undergo regular imaging to assess tumor response and other outcomes such as progression-free and overall survival, duration of response, and treatment safety for up to 30 months. The study requires close monitoring of health status including blood counts and organ function, with continued evaluation of side effects and treatment impact throughout the trial period.

Evaluating NALIRIFOX vs Modified Gemcitabine, Nab-Paclitaxel and Cisplatin in Patients With Locally Advanced and Metastatic Pancreatic Adenocarcinoma