Secondary Resectability In Locally Advanced Pancreatic Cancer (Lapc) After Nab-Paclitaxel/Gemcitabine- Versus Folfirinox-Based Induction Chemotherapy: Interim Results Of A Randomized Phase Ii Aio Trial (Neolap).

348Background: Although there is a strong rationale for downstaging non-resectable pancreatic ductal adenocarcinoma (PDAC) for secondary resections by multi-agent chemotherapy, evidence from prospective randomized studies is missing. Methods: This prospective, randomized, open-label, phase II study aims to assess the activity, safety and feasibility of nab-paclitaxel/gemcitabine (nPG)- and FOLFIRINOX-based induction chemotherapy for patients (pts) with non-resectable PDAC. After two cycles of nPG pts are randomly allocated to receive either two additional cycles of nPG (arm A) or four cycles of FOLFIRINOX (arm B). Secondary resectability is assessed by exploratory laparotomy in all pts with at least stable disease (SD) after induction chemotherapy. The primary endpoint is to compare secondary complete macroscopic resection rates (R0/R1) in both arms. Results: We report the results of a planned interim (futility) analysis for efficacy data after at least 50 patients had completed induction chemotherapy and...