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

Brief summary public domain (ClinicalTrials.gov)

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.

Detailed description public domain (ClinicalTrials.gov)

This is a prospective, interventional, non-randomized, open-label pilot study designed to evaluate the safety and performance of the Extroducer® Infusion Catheter System for peri- and intratumoral delivery of Gemcitabine in patients with unresectable Locally Advanced Pancreatic Cancer (LAPC). The study uses a dose-escalation design with three sequential cohorts to assess the feasibility and safety of repeated peri-/intratumoral Gemcitabine infusions at dose levels of 100 mg, 200 mg, and 400 mg. Each patient is planned to receive four study treatment sessions administered every two weeks. Following completion of the treatment phase, patients will be followed for 6 months until study completion. The total study participation per patient is expected to be approximately 8-9 months. Each cohort will include three patients. After completion of study treatment by all patients in a cohort, the Data Safety Monitoring Board (DSMB) will review safety data and determine whether dose escalation is appropriate based on the occurrence of study-defined dose-limiting toxicities (DLTs), and will recommend the dose level for the next cohort. A total of nine eligible participants are planned to be enrolled at one study site in Sweden.