Y90 Radioembolization Prior to Surgical Resection or Radiofrequency for Hepatocellular Carcinoma in Cirrhotic Liver (TRYPHON)

Inclusion Criteria:

• Age ≥18 years.
• Cirrhotic liver demonstrated by typical liver dysmorphy on imaging and/or liver biopsy.
• HCC with at least one lesion measuring more than 1 cm in diameter with a single dynamic imaging technique (CT or MRI), showing intense arterial uptake followed by washout of contrast in the venous-delayed phases, or diagnosed by biopsy.
• Borderline resectable disease eligible for surgical resection or radiofrequency destruction.
• No extra-hepatic dissemination.
• ECOG Performance status < 2.
• Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Signed written informed consent (approved by an Independent Ethics Committee) obtained prior to any study specific baseline procedures.

Exclusion Criteria:

• Decompensated cirrhosis (Child Pugh B, C).
• Extra-hepatic tumour spread.
• Previous or concomitant malignancies within five years other than basal cell carcinoma of the skin.
• Pregnancy, lactation or refusal to use adequate contraceptive measures (hormonal or barrier method of birth control, abstinence).
• Pre-existing other hepatic disease (liver abscess, hepatic sarcoidosis or tuberculosis, sclerosing cholangitis, …).
• Previous trans-arterial radioembolization (TARE).
• History of allergic reactions attributed to compounds of similar chemical or biologic composition of the administered materials.
• Bleeding diathesis, history of cardiovascular ischemic disease or cerebrovascular incident within the last six months.
• Major surgery within four weeks.
• Uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Uncontrolled Diabetes.