Safety and Performance of a Novel Infusion Catheter System for Peri/Intratumoral Gemcitabine Delivery in Patients With Pancreatic Cancer

Inclusion Criteria: * Able to comply with scheduled visits, treatment plan, able to undergo catheterization, imaging procedures, laboratory tests, required follow up visits, the filling out of required forms, and have the ability to understand and give written informed consent. * Voluntarily agrees to participate and has duly singed the Informed Consent Form. * Age 18 years or older. * Histologically confirmed, locally advanced pancreatic cancer. * Systemic treatment with IV chemotherapy for at least six months. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * The target tumor is a measurable tumor according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria v1.1 prior to initiating Extroducer® Gemcitabine treatment. * Stable disease or locally progressive disease without signs of metastatic disease as evaluated at a multidisciplinary tumor board within 4 weeks prior to first dose. * Locally Advanced Pancreatic Cancer not amenable to resection as evaluated at a multidisciplinary tumor board within 4 weeks prior to first dose. * Have acceptable organ and marrow function as defined below: i. Absolute neutrophil count (ANC) ≥ 1500 cells/mm³ (1.5x109 cells/L) ii. Hemoglobin ≥ 9.0 g/dL iii. Platelets ≥ 100,000/µL iv. Total bilirubin ≤ 2 × upper limit of normal (ULN). v. AST (Aspartate Aminotransferase) ≤ 3 × ULN. vi. ALT (Alanine Aminotransferase) ≤ 3 × ULN vii. Creatinine Within 1.5 x ULN OR Creatinine clearance ≥ 60 mL/min for pa…