Bridge to Orthotopic Liver Transplantation (OLT) - Surefire Precision vs Endhole Embolization With DEBTACE

This is a single institution prospective clinical trial with historical matched controls.
This protocol standardizes DEB-TACE delivery with the Surefire Precision Infusion System.
This protocol does not change patient therapy. All patient safety monitoring, treatment
procedures and follow-up procedures will be performed in accordance with standard clinical
practice.

Fifty (50) subjects will be enrolled in the prospective arm. Data from one hundred (100)
historical randomly sampled control subjects (1:2 ratio) will be selected.

Subjects will be followed at 1 week, 1 month, 3 months, then every 3 months, following the
initial DEB-TACE procedure until the subject receives a liver transplant or death. The study
will be concluded upon completion of enrollment and follow-up of the 50 patients. It is
estimated that the time to complete patient enrollment and follow-up is 24 months. The
estimated date for study completion (complete primary analyses) is June 2018. This is based
on the average survival vs. time to transplant at this center. If there are individual
patients that extend beyond this period the time may be slightly extended.

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