Phase 2 Study of Alternating Neoadjuvant Chemotherapy with Gemcitabine plus Nab-Paclitaxel and Modified FOLFIRINOX for Borderline Resectable Pancreatic Cancer

What this Trial Is About

Researchers are studying the effects and safety of alternating two chemotherapy treatments, gemcitabine plus nab-paclitaxel GnP and modified FOLFIRINOX mFOLFIRINOX, in patients with borderline resectable pancreatic ductal adenocarcinoma BR-PDAC. These treatments are FDA-approved for this condition, and alternating them aims to improve how well the cancer responds to therapy, increase the chance of successful tumor removal, and reduce the risk of cancer recurrence. Participants will receive GnP on days 1, 8, and 15 during cycles 1 and 3, and mFOLFIRINOX on days 1 and 15 during cycles 2 and 4, with each cycle lasting 28 days. This neoadjuvant chemotherapy is given before surgery, following recommendations by treating physicians. The study is a single-group, phase 2 clinical trial that evaluates this alternating treatment approach. During the study, participants will undergo contrast-enhanced CT scans of the chest, abdomen, and pelvis, as well as regular assessments of tumor response, surgical resection outcomes, and survival rates for up to one year. Researchers will monitor safety, treatment completion, dose changes, and cancer recurrence. The main measurement is one-year event-free survival. Participation lasts until surgery and follow-up evaluations, with data collected to assess the effectiveness and safety of the alternating chemotherapy regimen.

24BRO681 : Alternating Gnp and mFOLFIRINOX for BR-PDAC