Clinical Research Directory

CT-guided Percutaneous Radionuclide Therapy With 32P Microparticles in Patients With Non-progressive Locally Advanced Pancreatic Cancer

Sponsor: M.R. Meijerink

Summary

Pancreatic ductal adenocarcinoma is a highly lethal cancer, and approximately 40% of patients present with non-metastatic locally advanced pancreatic cancer (LAPC) that is not suitable for surgical resection. To improve outcomes in this patient group, local ablative treatments are being explored. Radionuclide therapy (RNT) is a promising option that delivers high-dose internal radiation directly into the tumor, potentially achieving better local tumor control while sparing surrounding tissues compared with external-beam radiation therapy. The OncoSil™ device is a type of RNT containing Phosphorus-32-radiolabeled microparticles. The ³²P microparticles have been designed to deliver a localized distribution of beta-radiation within the target tumor up to 100 Gy, which causes direct damage to cancer cell DNA and renders them incapable of further cell division and proliferation. Favorable results have been reported by implanting ³²P microparticles intra-tumorally, which is typically administered via endoscopic ultrasound guidance. A percutaneous approach may allow for more precise and reproducible delivery, but prospective data on its safety and feasibility are lacking. This prospective, single-arm phase 1-2 feasibility study aims to evaluate the safety and feasibility of percutaneous CT- guided RNT using ³²P microparticles in patients with non-progressive LAPC following induction chemotherapy. Twenty adult patients with pathology-confirmed LAPC, showing non-progressive disease according to RECIST, will be included after multidisciplinary tumor board review. Patients will undergo percutaneous, CT-guided implantation of ³²P microparticles under general anesthesia, sedation, or local analgesia depending on study phase and clinical judgment, followed by continuation of standard systemic chemotherapy and routine follow-up. The primary endpoint is the rate of adverse events (CTCAE grade ≥3) occurring during the procedure and within 90 days afterward. Secondary endpoints include technical success, all adverse events, best overall respons, overall and progression-free survival, and changes in tumor markers.

Official title: Safety and Feasibility of CT-guided Percutaneous Radionuclide Therapy With 32P Microparticles in Patients With Non-progressive Locally Advanced Pancreatic Cancer (PANCOSIL): an Open-label, Single-arm Phase 1-2 Feasibility Study

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