A Single-center, Prospective, Non-randomized, Open, Pilot Study Evaluating the Safety and Performance of the Extroducer® Infusion Catheter System for Peri/Intratumoral Gemcitabine Delivery in Patients with Unresectable Locally Advanced Pancreatic Cancer

Condition studied

Unresectable Locally Advanced Pancreatic Cancer

Investigational medicinal product(s)

Eligibility

Primary endpoint

Occurrence of Extroducer® related Serious Adverse Events within 72 hours post Extroducer® treatment infusion with Gemcitabine.

Endpoint detail

Occurrence of Gemcitabine related Serious Adverse Events from first Extroducer® treatment infusion with Gemcitabine until study completion., Survival rates (Overall Survival (OS) and Progression Free Survival (PFS)) at 6 months after final Extroducer® treatment infusion with Gemcitabine., Classification of tumor resectability according to NCCN resectability criteria before (baseline) and after (Visits 11-13) Extroducer® treatment infusion with Gemcitabine., Classification of tumor response according to RECIST before (baseline) and after (Visits 11-13) Extroducer® treatment infusion with Gemcitabine., Evaluation of the tumor marker CA-19-9 before (baseline) and after (Visits 9, 11-13) Extroducer® treatment infusion with Gemcitabine., Evaluation of subjects’ quality of life using the EORTC QLQ-C30 and PANC26 questionnaires before (baseline) and after (Visits 11-13) Extroducer® treatment infusion with Gemcitabine., The incidence, severity, and seriousness of Adverse Events and Device Deficiencies throughout the clinical investigation.