Bridge to Orthotopic Liver Transplantation (OLT) - Surefire Precision vs Endhole Embolization With DEBTACE (SPEED)
Hepatocellular Carcinoma of the Liver, Subjects Eligible for Liver Transplantation

About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma of the Liver
Eligibility Criteria
Inclusion Criteria:
- Patients aged 18 years or older with the diagnosis of HCC currently being evaluated for liver transplantation and considered for downstaging.
- Patients undergoing Surefire DEB-TACE procedure as clinically determined
- Single tumor that is >5 cm and less than 8 cm, OR 1 to 3 tumors with combined diameter greater than 15 cm and less than 24 cm
- No portal invasion or extrahepatic spread
- No previous chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Preserved liver function (Child-Pugh Class A or B).
- Discrete hepatic artery feeding the tumor with vessel diameter > 1.5 mm
Exclusion Criteria:
- Advanced bilirubin levels > 3 mg/dl
- AST or ALT>5 upper limit of normal or >250 U/l
- Advanced tumoral disease, defined as vascular invasion, extrahepatic spread, or diffuse HCC (50% liver involvement)
- Contraindications for doxorubicin administration.
- Child's Class C
- Vessels providing flow to the tumor that are less than 1.5 mm in diameter
Sites / Locations
- University of Colorado Hospital
Arms of the Study
Arm 1
Experimental
DEB-TACE Procedure with Surefire Precision Infusion System
The study duration for each patient is 24 months and includes a baseline visit, procedure visit and follow-up visits at 1 week, 1 month, 3 months, 6 months and every 3 months until liver transplant or death. The following evaluations/activities will be performed at baseline: Informed consent, history, physical exam, data collection of CT/ MRI within 1 month of the visit date, data collection of lab values and quality of life questionnaire. The treatment visit includes the DEB-TACE procedure with the Surefire Precision Infusion System. After the procedure, a Cone Beam CT of the liver will be performed to determine distribution and density of the beads in the tumor and adverse events monitoring. The following evaluations / activities will be performed during the follow-up period: physical exam, data collection of contrast enhanced CT/MRI to evaluate tumor response, data collection of lab values, adverse event monitoring and quality of life questionnaire.