Brief Report: A Phase 1 Study Evaluating Extracorporeal Blood Purification to Remove Circulating Tumor Cells in Patients with Metastatic Pancreatic Adenocarcinoma

IntroductionPancreatic ductal adenocarcinoma (PDAC) is the eighth most common malignancy and patients have a 5-year survival rate of less than ten percent. Early studies suggest that extracorporeal removal of circulating tumor cells and particles may improve both clinical symptoms and cachexia. This study reports the first controlled trial of CTC removal in patients with Stage 4 PDAC. MethodsFive patients were consented under a US FDA investigational device exemption (IDE) for a single treatment of the ONCObind procedure using the Seraph 100 filter. All patients received a double-lumen catheter and underwent an extracorporeal blood purification treatment with the Seraph 100 for 3 hours. Pain scores, circulating tumor cell levels, and erythrocyte sedimentation rates were measured at baseline and post-treatment. Adverse events were carefully monitored during the procedure. At the end of the procedure, the vascular catheter was removed. ResultsAll patients tolerated the procedure well and no treatment-emergent adverse events were reported during the ONCObind procedure. Patients demonstrated a decrease in CTC levels from a baseline of 3016 + 1924 cell/mL compared to post-treatment levels of 1410 + 1564, p = 0.03. The sedimentation rate decreased from a baseline of 41.8 + 51.0 to a post-treatment level of 29.2 + 11.6, p = 0.50. The mean pain score improved from a mean of 3.8 +1.8 to a post-treatment level of 1.3 + 1.5, p = 0.04. ConclusionsThe ONCObind treatment procedure was feasible and well tolerated in a small cohort of patients with metastatic PDAC. Future studies are warranted.