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

Free University of Brussels (ULB)

Status and phase

Terminated

Phase 2

Conditions

Liver Cirrhosis

Hepatocellular Carcinoma

Treatments

Device: Sirsphere trans-arterial radioembolization

Study type

Interventional

Funder types

Other

Identifiers

NCT01686880

TRYPHON

Details and patient eligibility

About

The purpose of this study is to assess the safety of transarterial radioembolization prior to surgical resection or radiofrequency in cirrhotic patients with hepatocellular carcinoma

Full description

The purpose of this study is to assess the peri-operative morbidity and mortality of supraselective ablative transarterial radioembolization prior to surgical resection or radiofrequency in cirrhotic patients with HCC

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.