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Effect of Surefire Infusion Device on Tumor Response to Regional Intra-arterial Therapy for Primary Liver Malignancies

Liver Cancer Clinical Trial

Official title:
Effect of Surefire Infusion Device on Tumor Response to Regional Intra-arterial Therapy for Primary Liver Malignancies

Clinical Trial Summary

This research study is studying the TriNav ("TriSalus") for increasing delivery of chemotherapeutic agents delivered trans-arterially to intermediate stage Hepatocellular Carcinoma ("HCC") (Barcelona Clinic Liver Cancer (BCLC) class B; locally advanced, liver restricted disease patients. The names of the study interventions involved in this study are: -Trans-arterial chemoembolization ("TACE") with or without the utilization of Surefire

Clinical Trial Description

This research study is a randomized Pilot study, which is the first time investigators are examining use of the TriNav device to improve tumor perfusion. Specifically, this study compares TACE both with or without the use of the TriNav device Investigators are doing this research to determine if a TriNav Infusion System can improve tumor response to liver-directed intra-arterial chemotherapy compared to a traditional microcatheter. TriNav is a Food and Drug Administration-approved valve-like device that blocks backflow within the artery but also generates increased pressure in a tumor feeder vessel during infusion. During this study, participants will receive the same medication in the same dose and the same way it would be delivered to the liver as a standard of care procedure, only either through a regular microcatheter (which is the standard of care procedure) or a TriNav Infusion System (which is a modified microcatheter). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02853500
Study type Interventional
Source Dana-Farber Cancer Institute
Contact Dmitry Rabkin, MD, PhD
Phone 617-732-7240
Status Recruiting
Phase N/A
Start date July 2016
Completion date July 2027
View Details
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