Pilot Study Evaluating Safety of Extroducer Infusion Catheter System for Direct Gemcitabine Delivery in Patients With Unresectable Locally Advanced Pancreatic Cancer

What this Trial Is About

Researchers are evaluating a new method to deliver the chemotherapy drug Gemcitabine directly into or near pancreatic tumors using the Extroducer4 Infusion Catheter System. This study focuses on patients with locally advanced pancreatic cancer that cannot be removed by surgery and aims to assess the safety and feasibility of this treatment approach. The trial is a prospective, interventional, open-label pilot study with a dose-escalation design involving three groups of patients receiving increasing doses of Gemcitabine. Participants will receive four treatment sessions spaced two weeks apart, with Gemcitabine infused via the Extroducer catheter system at doses of 100 mg, 200 mg, or 400 mg depending on the cohort. After each cohort completes treatment, an independent safety committee reviews data to decide if it is safe to proceed to the next dose level. Following treatment, patients will be monitored for six months to assess outcomes and safety. During the study, participants will undergo catheterization, imaging, laboratory tests, and follow-up visits including quality of life assessments. The main outcome measured is serious adverse events related to the Extroducer system within 72 hours after treatment. Secondary outcomes include Gemcitabine-related adverse events, survival rates, tumor response, and patient quality of life over approximately eight months of participation. Total involvement in the study lasts about 8 to 9 months.

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