Phase 2 Study of NALIRIFOX Chemotherapy Before Surgery for Borderline Resectable Pancreatic Ductal Adenocarcinoma

What this Trial Is About

Researchers are studying how well a combination of chemotherapy drugs called NALIRIFOX works before surgery in patients with borderline resectable pancreatic ductal adenocarcinoma. This phase II trial aims to assess the treatments ability to shrink tumors and improve surgical outcomes, as well as to evaluate its safety and identify biomarkers related to patient outcomes. The study is sponsored by Roswell Park Cancer Institute. Participants receive NALIRIFOX, which includes liposomal irinotecan, oxaliplatin, leucovorin, and fluorouracil, given through intravenous infusions. Treatment cycles occur every 14 days for 4 to 8 cycles before surgery. Surgery to remove the tumor is scheduled 4 to 8 weeks after the last treatment. Starting 4 to 12 weeks post-surgery, patients may receive up to 4 more cycles of NALIRIFOX if their disease does not progress or if side effects are manageable. Throughout the study, patients undergo CT scans and blood sample collections. During participation, patients are closely monitored with imaging and laboratory tests to evaluate treatment effects and safety. After completing the treatment phases, follow-up visits occur within 30 days, then every 3 to 6 months for 2 years, and subsequently every 6 to 12 months for up to 5 years. Researchers will assess major pathologic response, survival rates, disease progression, and adverse events to understand the treatments impact over time.

NALIRIFOX Before Surgery for the Treatment of Borderline Resectable Pancreatic Ductal Adenocarcinoma, Nectar Trial