Downstaging locally advanced pancreatic cancer using endovascular light-activated ablation
Background
Circa 30-40% of pancreatic cancers can involve intrapancreatic large blood vessels early, making complete tumor resection technically challenging or impossible. A treatment that clears vessels from encasing tumors is needed so more patients can undergo curative surgery. We hypothesize that effective ablation of perivascular tumors is possible through Endovascular Light-activated Ablation (ELA).
Start-up company Vascular Oncology Biotechnologies B.V. completed a dose-escalating proof-of-concept study in a preclinical model, confirming substantial perivascular necrosis can be generated in the pancreas following a dose response, while the vessel wall remained substantially intact 2-7 days after treatment, in a dose independent fashion. Based on these encouraging results we are now initiating a clinical study within the AmsterdamUMC, RadboudUMC and UMC Groningen, as the next logical step.
Objective
Evaluate the safety and feasibility of Endovascular Light-activated Ablation in patients with pancreatic cancer using an endovascular near-infrared laser irradiation.
Design
A near-infrared irradiation system will be developed and interfaced with novel endovascular EPA balloon catheters, including IMDD documentation for METC approval. Treatment planning software will be developed and integrated into a software package ready for use in the clinical study. 12 patients scheduled for distal pancreatectomy with resection of the splenic vessels will be enrolled. Four cohorts will be treated with perivascular EPA utilizing two increasing dose levels and two delivery approaches (i.e. endo-venous and endo-arterial), followed by the scheduled distal pancreatectomy within 3-7 days. Primary endpoint will be safety as measured by complication rate, feasibility of resection post-ELA and histopathological assessment of vessel wall integrity. Lastly the biological effects of endovascular ELA are investigated, focusing on vascular wall damage and immune response.
