Treatment With Yttrium90 Radioembolization Prior to Surgical Resection or Radiofrequency for Hepatocellular Carcinoma in Cirrhotic Liver
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.