Presentation of Data on Intra-arterial Targeted Delivery of Gemcitabine in Treatment of Loco-regional Pancreatic Tumors

Illustration of RenovoRx Two Balloons Delivery System

Aim: A dose-escalation study of Gemcitabine for treatment of unresectable pancreatic cancer, using a targeted intra-arterial delivery catheter (RenovoCath™).

Methods: 20 patients at two centers were enrolled with a fourstage dose escalation of gemcitabine up to 1000 mg/m2. Enzyme markers, blood count, and constitutional endpoints were monitored to assess for dose-limiting toxicities. Feasibility and safety of repeated intra-arterial treatment sessions were assessed. Secondary endpoints included the effect on tumor size by imaging, tumor markers, and conversion to resectability.

Results: Data for 20 patients enrolled is presented. Efficacy analysis was limited to the 15 patients who received more than two treatments.

SUMMARY: Intra-arterial delivery of gemcitabine using localized delivery catheter, RenovoCath, is safe provided:

  • Patients with prior biliary stent/drain receive peri-op antibiotics
  • IR training/support is necessary to avoid guide mediated vascular complications
  • Early efficacy results of survival is encouraging, especially in patients with prior radiation where there may exist a synergistic effect with localized trans-arterial delivery of gemcitabine

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