Study Comparing Targeted Intra-arterial Gemcitabine Versus Continuing IV Gemcitabine Plus Nab-Paclitaxel After Initial Treatment and Radiation for Locally Advanced Unresectable Pancreatic Cancer

What this Trial Is About

The trial investigates treatment options for adults with locally advanced pancreatic adenocarcinoma that cannot be removed by surgery. It compares the effects of delivering the chemotherapy drug gemcitabine directly into the artery versus continuing standard intravenous chemotherapy with gemcitabine plus nab-paclitaxel, following initial radiation therapy. The purpose is to evaluate overall survival and other outcomes in this patient group under a phase 3 clinical study. All participants first receive induction therapy consisting of intravenous gemcitabine plus nab-paclitaxel along with stereotactic body radiation therapy SBRT over about four months. Those who remain eligible are then randomly assigned to one of two groups one group receives intra-arterial gemcitabine via the RenovoCath device every other week for up to 16 weeks, while the other group continues intravenous gemcitabine and nab-paclitaxel on a 28-day cycle for 16 weeks. After this, both groups may receive intravenous gemcitabine plus nab-paclitaxel or oral capecitabine until their disease progresses. Participants undergo regular assessments including imaging, laboratory tests, and evaluations of health-related quality of life and neuropathy. Researchers monitor overall survival for up to five years, as well as progression-free survival, response rates, safety, and tolerability. The study includes follow-up for survival outcomes and adverse events, with monitoring continuing for up to five years after treatment.

Intra-arterial Gemcitabine vs. IV Gemcitabine and Nab-Paclitaxel Following Radiotherapy for LAPC