Abstract
Introduction Pancreatic 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.
Methods Five 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.
Results All 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.
Conclusions The ONCObind treatment procedure was feasible and well tolerated in a small cohort of patients with metastatic PDAC. Future studies are warranted.
Competing Interest Statement
Advisory Board: Eisai, Astra Zeneca, IgM Biosciences; TAPUR ASCO Data Safety Monitoring Committee Exthera Medical
Clinical Trial
NCT06481397
Funding Statement
This study was funded by Exthera Medical
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Study was conducted under an open FDA investigational device exemption (IDE-G230144) NCT06481397 The study was approved by the central IRB Advarra (IRB ID #Pro00079800)
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