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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Hepatocellular Carcinoma, Liver Cirrhosis

Intervention / Treatment
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* Device: Sirsphere trans-arterial radioembolization


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preoperative aTARE<br>The patients in this arm will receive Sirsphere trans-arterial radioembolization before surgery | Device: Sirsphere trans-arterial radioembolization<br>* Patients will receive Sirsphere trans-arterial radioembolization before surgery<br>* Other names: SIRT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri-operative morbidity | 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) | 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Assessment of the overall disease free survival and Overall Survival | 3 years | 
| One and three years survival | Estimation of disease free survival and overall survival rates after 1 and 3 years | one and three years | 
| Tumor regression | Assessment of tumour size regression after Trans-arterial radioembolization by MRI | 8 weeks after Trans-arterial radioembolization | 
| Functional Imaging | 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. | 3 years | 
| Contra-lateral Lobe Hypertrophy | Assessment of TARE induced liver contralateral lobe hypertrophy (volumetric measurement by MRI). | 3 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SIRT, Hepatocellular Carcinoma, Liver Cirrhosis, radioembolization, TARE, Sirspheres, neoadjuvant, liver cancer