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

Phase 2

Terminated

• Conditions: Hepatocellular Carcinoma; Liver Cirrhosis
• Interventions: Device: Sirsphere trans-arterial radioembolization

• Registration Number: NCT01686880
• Lead Sponsor: Jules Bordet Institute

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-11
• Study First Submitted QC: 2012-09-13
• Study First Posted: 2012-09-18
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-30
• Last Update Posted: 2015-07-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Preoperative aTARE	Sirsphere trans-arterial radioembolization	The patients in this arm will receive Sirsphere trans-arterial radioembolization before surgery

Primary Outcome Measures

Name	Time	Method
Peri-operative morbidity	3 months after surgery	peri-operative morbidity of supraselective ablative transarterial radioembolization prior to surgical resection or radiofrequency in cirrhotic patients with HCC (starting from date of inclusion till 90 days after surgery or hospital discharge if more than 90 days)

Secondary Outcome Measures

Name	Time	Method
Functional Imaging	3 years	Assessment of imaging parameters changes (DW-MRI, FDG-PET/CT) and MAA-SPECT-CT in relation to the outcome measured by tumour regression after TARE, disease free and overall survival.
Contra-lateral Lobe Hypertrophy	3 Years	Assessment of TARE induced liver contralateral lobe hypertrophy (volumetric measurement by MRI).
Survival	3 years	Assessment of the overall disease free survival and Overall Survival
One and three years survival	one and three years	Estimation of disease free survival and overall survival rates after 1 and 3 years
Tumor regression	8 weeks after Trans-arterial radioembolization	Assessment of tumour size regression after Trans-arterial radioembolization by MRI

Trial Locations

Locations (2)

Institut Jules Bordet; 🇧🇪 Brussels, Belgium

Erasme Hosptial; 🇧🇪 Brussels, Belgium