Phase 1b/2 PRISM‑TAMP tests arterial gemcitabine chemotherapy microperfusion

University of Vermont is running this Phase 1b/2, single-arm, open-label study in borderline resectable pancreatic ductal adenocarcinoma to see whether adding trans-arterial microperfusion (TAMP) delivery of gemcitabine can be safely integrated into a modern neoadjuvant pathway and potentially improve margin-negative resections. Patients receive modified FOLFIRINOX (5‑FU-based multi-agent chemotherapy) followed by stereotactic body radiation therapy, then locoregional gemcitabine via the RenovoCath catheter system (RenovoRx) to perfuse tumor-feeding arterial supply; gemcitabine is a nucleoside analog whose active metabolites inhibit ribonucleotide reductase and are incorporated into DNA, disrupting DNA synthesis. The main focus is safety/tolerability and feasibility of this perioperative, device-enabled chemo delivery, with key secondary readouts including pathologic regression and intraoperative margin status after surgery. Commercially and scientifically, the angle is “better drug delivery” rather than a new drug: it tests whether concentrating a familiar cytotoxic in the pancreas can push down positive-margin rates without prohibitive toxicity. Today’s care for borderline resectable PDAC is multi-agent neoadjuvant chemotherapy (commonly modified FOLFIRINOX) often followed by chemoradiation/SBRT and then surgery when feasible, yet incomplete regression and R1 resections remain common.