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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
Full 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).
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Inclusion criteria
Unresectable HCC, defined by imaging criteria or cytohistologic assessment. TACE as a preferred method of treatment is determined by a multidisciplinary Brigham and Women's Hospital / Dana Farber Cancer Institute (BWH/DFCI) Liver Tumor Board.
Intermediate stage HCC (BCLC class B), not eligible for curative treatment, but with Child-Pugh A or B. Additionally, tumor cannot involve greater than 50% of the entire liver.
Prior systemic chemotherapy is allowable.
Age 18-75 years. The pediatrics population is not included as this disease has very low prevalence in that population.
Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%, see Appendix A)
Life expectancy of greater than at least 12 months.
Participants must have normal organ and marrow function as defined below:
No previous regional treatment (includes surgery, radiation or liver-directed arterial or ablative therapy).
Main tumor size > 1 cm
The effects of the study arm on the developing human fetus are unknown, however they are no different than for those in the control group. In addition, because significant radiation will be delivered during the procedure, a positive pregnancy test will exclude patients from the study in addition to excluding them from receiving standard therapy.
Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
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10 participants in 2 patient groups
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Central trial contact
Dmitry Rabkin, MD, PhD
Data sourced from clinicaltrials.gov
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