OncoSil Medical has achieved a significant milestone in expanding treatment options for locally advanced pancreatic cancer (LAPC) patients, treating the first patient in the PANCOSIL clinical trial on November 28, 2023. The investigator-initiated study represents a novel approach to delivering the OncoSil™ device through CT-guided percutaneous implantation rather than the currently approved endoscopic method.
Trial Design and Objectives
The PANCOSIL trial is evaluating the safety and feasibility of CT-guided percutaneous radionuclide therapy using the OncoSil™ device in patients with non-progressive locally advanced pancreatic cancer. The study will treat 20 patients with the OncoSil™ device through percutaneous application, expanding beyond the original 15-patient design approved by the ethics committee in June 2023.
Professor Marc Besselink, the lead investigator at Amsterdam UMC and a leading hepato-pancreato-biliary surgeon in Europe, emphasized the significance of this approach for patients with poor prognosis. "I am excited to be part of an innovative Clinical Trial in developing the percutaneous application of the OncoSil™ device for patients with Locally Advanced Pancreatic Cancer, who have stable disease after several months of chemotherapy," Besselink stated.
Technical Advantages of Percutaneous Delivery
The percutaneous approach offers several potential clinical advantages over the current endoscopic method. Professor Martijn Meijerink highlighted the precision benefits, stating: "This novel means of implantation of the OncoSil™ device has a number of potential advantages, such as the ability to more precisely place the radioactive microparticles within the pancreatic tumour in a simpler procedure."
The CT-guided percutaneous method involves inserting a needle directly through the skin into the pancreatic tumor under CT guidance, contrasting with the current endoscopically guided ultrasound approach. This technique can be performed by interventional radiologists, many of whom have experience working with radionuclide therapies for various malignant diseases.
Expanding Treatment Accessibility
A key objective of the PANCOSIL trial is to increase the number of medical professionals capable of delivering OncoSil™ treatment. Professor Besselink explained the broader clinical impact: "Eventually, we aim to give caregivers more flexibility to treat their patients with Locally Advanced Pancreatic Cancer with OncoSil™ as they will have the ability to select the route of administration of the device based on the tumour location, patient preference and the availability of different specialists within the multidisciplinary treatment team."
The study is designed to develop a feasible and safe standardized approach for percutaneous application of the OncoSil™ device, with results intended to support regulatory submissions for this alternative delivery method. OncoSil Medical is providing the doses at no cost for the trial and making a modest contribution to study personnel, with the majority of the company's funding contribution having occurred in previous quarters.
Clinical Context and Patient Population
The trial targets patients with locally advanced pancreatic cancer who have stable disease following several months of chemotherapy. This patient population faces particularly challenging prognoses, making the development of alternative treatment delivery methods clinically significant.
The PANCOSIL study represents part of OncoSil Medical's broader strategy to expand treatment options for LAPC patients through their localized radionuclide therapy approach. The company's focus on developing multiple delivery methods for the OncoSil™ device reflects the complex anatomical and clinical considerations involved in treating pancreatic cancer patients.
