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

This study is testing a new way to deliver the chemotherapy drug Gemcitabine in pancreatic tumors using the catheter Extroducer® Infusion Catheter System. The study will include patients with Locally Advanced Pancreatic Cancer that cannot be removed with surgery. Patients will receive four treatment sessions, given every two weeks, in which Gemcitabine is infused directly into or near the tumor. The study will test up to three increasing dose levels of Gemcitabine (200 mg, 400 mg, and 100 mg). The study will enroll three groups of three patients each. After each group completes treatment, an independent safety committee will review the results to decide whether it is safe to move to the next dose per predefined study criteria. After finishing treatment, patients will be followed for six months. Each patient's total participation in the study will last about 8-9 months. The main goal of the study is to evaluate the safety and feasibility of this treatment approach.

NCT Number	NCT07575191
Lead Sponsor	Smartwise Sweden AB
Conditions	Pancreatic Cancer Non-resectable
Enrollment	9 participants
Start Date	2026-04-29
Primary Completion	2027-12 (estimated)
Study Completion	2028-06 (estimated)
Updated on ClinicalTrials.gov	2026-06-12