Phase 2 Study of 5-FU with Nanoliposomal Irinotecan or Nanoliposomal Irinotecan Plus Oxaliplatin for Metastatic Pancreatic Ductal Adenocarcinoma After Gemcitabine Treatment

What this Trial Is About

Researchers are evaluating the effectiveness of two chemotherapy combinations, 5-FU with nanoliposomal irinotecan NALIRI and 5-FU with nanoliposomal irinotecan plus oxaliplatin NALIRINOX, in patients with metastatic pancreatic ductal adenocarcinoma PDAC who have progressed after treatment with Gemcitabine-Abraxane or Gemcitabine alone. This phase 2 randomized study aims to assess the progression-free survival rate and safety of these treatments in fit patients with good performance status. Participants receive treatment in 14-day cycles. In the NALIRI group, patients are given leucovorin, nanoliposomal irinotecan at 70 mgm, and 5-FU through intravenous infusion. The NALIRINOX group receives oxaliplatin, leucovorin, nanoliposomal irinotecan at 50 mgm, and 5-FU. The study monitors dosing adjustments based on individual tolerance, especially for patients with specific genetic markers. Treatments are administered mostly via intravenous infusions over several hours and continuous infusions over two days. During the study, participants undergo regular imaging scans, tumor marker tests, and safety assessments to evaluate treatment response and side effects. Researchers track progression-free survival at day 85 post-randomization and continue monitoring survival and disease control for up to five years. Safety is closely followed through laboratory tests, physical exams, and adverse event reporting until two weeks after treatment ends. The total participation time varies depending on individual treatment response and follow-up duration.

A Study Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for PDAC (NALPAC)