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.
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.
Participating in another clinical investigation which may interfere with the results in this clinical investigation per investigator judgement.
Inability to consent.
Pancreatic tumor is different from adenocarcinoma (e.g., neuroendocrine, metastases). Adenosquamous is allowed.
Cancer has spread to other organs or non-regional lymph nodes (Metastases).
Sequential
Gemcitabine
DrugGemcitabine administered via the Extroducer Infusion Catheter System for targeted delivery.
Extroducer Infusion Catheter System
DeviceInfusion catheter system for delivery of diagnostic or therapeutic agents into the extravascular space or peripheral vasculature.
Extroducer® related Serious Adverse Events
Occurrence of Extroducer® related Serious Adverse Events within 72 hours post Extroducer® treatment infusion with Gemcitabine.
Gemcitabine related Serious Adverse Events
Occurrence of Gemcitabine related Serious Adverse Events from first Extroducer® treatment infusion with Gemcitabine until study completion.
Overall Survival
Overall Survival (OS) at 6 months after final Extroducer® treatment infusion with Gemcitabine.
Progression Free Survival
Progression Free Survival (PFS) at 6 months after final Extroducer® treatment infusion with Gemcitabine.
Tumor resectability
Classification of tumor resectability according to NCCN resectability criteria before (baseline) and after (Visits 11-13) Extroducer® treatment infusion with Gemcitabine.
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