SIR 2024
Interventional Oncology
Rahul A. Sheth, MD
Associate Professor
University of Texas MD Anderson Cancer Center
Financial relationships: Full list of relationships is listed on the CME information page.
Dan Zhao, MD
Assistant Professor
University of Texas MD Anderson Cancer Center
Disclosure information not submitted.
Michael Lee, MD
Associate Professor
University of Texas MD Anderson Cancer Center
Disclosure information not submitted.
The PERIO-03 study (NCT05607953) is a Phase 1/1b trial evaluating a novel transhepatic endovenous intratumoral immunotherapy intervention for patients with unresectable locally advanced pancreatic ductal adenocarcinoma (PDAC). Here, we report the technical success and procedural safety of the first 5 patients enrolled in this ongoing clinical trial.
Materials and Methods:
The PERIO-03 trial utilizes a uniquely designed occlusive catheter (TriSalus Infusion System (TIS), TriSalus Life Sciences) for the delivery of the immunotherapeutic agent, SD-101, via Pancreatic Retrograde Venous Infusion (PRVI). PRVI allows for the drug to be delivered directly to the tumor by retrograde infusion into the tumor draining veins. In this study, portal venous access is obtained via percutaneous transhepatic approach. Target vein(s) that drain from the pancreatic tumor are identified angiographically. Prior to SD-101 delivery, outflow veins that do not drain the tumor and which could lead to off-target delivery are coil embolized. Next, through a 7Fr guide catheter and over a stiff 0.018” microwire, the TIS device is advanced into the target vein(s). The pressure-modulating occlusive valve on the device is then deployed, and SD-101 is infused upstream into the tumor via hand delivery. Continuous pressure measurements are monitored to ensure venous occlusion upon valve deployment and to avoid over-pressurization during delivery. In the study, SD-101 is delivered over 2 cycles via PRVI. Enrollment in this study is ongoing.
Results:
A total of 5 patients have received 8 treatment interventions to-date in the PERIO-03 study. The most common site for tumor was at the pancreatic head (4/5) followed by the pancreatic body (1/5). All patients with pancreatic head tumors had metallic biliary stents in place prior to intervention, and all were treated from pancreatic veins draining into the superior mesenteric. The pancreatic body tumor was treated via a pancreatic vein draining into the splenic. Technical success, defined as the successful completion of SD-101 delivery into the target vein, was 100%. There were no immediate complications from the procedure, and there was no evidence of vascular injury (i.e. stenosis, spasm, or thrombosis) due to the TIS device. Continuous monitoring of pressure enabled infusions have occurred with the prescribed pressure range with each procedure to date.
Conclusion:
Current experience with the novel transvenous immunotherapy delivery intervention in the PERIO-03 study indicates that this PRVI procedure is technically feasible and safe.