Comparing Lipiodol/Ethanol With Drug-eluting Beads (DEB) for Hepatocellular Carcinoma

Study Overview
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Brief Summary
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Chemoembolization of hepatocellular carcinoma lesions is an accepted and frequently used method for the palliative or curative treatment of these lesions. These attempts are being made to make these patients a better candidate for liver transplant or to provide palliation for their condition.

Detailed Description
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This is a randomized prospective study with two arms, Drug-Eluting Beads with doxorubicin (DEB) and lipiodol ethanol mixture (LEM), with the goal to show non-inferiority of LEM, which if true will facilitate a simple alternative to DEBs. Patients will be randomized to one arm of the study and will remain in that arm if they need to have more embolization in the future. Both of the mentioned methods (DEB and LEM) fall within the standard of care.

Official Title
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Prospective Study Comparing Lipiodol Plus Ethanol Solution Compared With Drug-Eluting Beads for Trans-arterial Chemoembolization of Liver in Treatment of Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: Drug-Eluting Beads (DEB) with Doxorubicin
* Drug: Lipiodol Ethanol Mixture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child-Pugh class A or B Biopsy proven HCC or hypervascular mass per European Association for the Study of the Liver (EASL) criteria Patient not a candidate for surgical resection or percutaneous ablation age > 18 years old and able to consent Exclusion Criteria: Child-Pugh class C Model for End-Stage Liver Disease (MELD) score >16 Extrahepatic disease Bilateral or main portal vein thrombus Total bilirubin > 2.2 Serum albumin < 2.6 Life expectancy < 2 months Uncorrected INR > 2 Eastern Cooperative Oncology Group (ECOG) status > 2 Tumor burden > 50% liver volume Hepatofugal portal venous flow

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
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Drug-Eluting Beads with Doxorubicin<br>Drug-Eluting Beads (DEB) with Doxorubicin is administered via beads that release it to the liver through a groin puncture site and delivered via catheter through the vessels that feed the liver. | Drug: Drug-Eluting Beads (DEB) with Doxorubicin<br>* One treatment of Drug-Eluting Beads (DEB) with Doxorubicin administered to the liver through a groin puncture site and delivered through the vessels that feed the liver (per standard of care).<br>* Other names: Doxorubicin;|
| Active Comparator: Lipiodol Ethanol Mixture (LEM)<br>Lipiodol Ethanol Mixture (LEM) is administered to the liver through a groin puncture site and delivered via catheter through the vessels that feed the liver. | Drug: Lipiodol Ethanol Mixture<br>* One treatment of Lipiodol Ethanol Mixture (LEM) is administered to the liver through a groin puncture site and delivered through the vessels that feed the liver (per standard of care).<br>* Other names: LEM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients with Post-Embolization Syndrome | Count of patients with post-embolizaation syndrome reported which includes fatigue, anorexia, nausea, fever. | Week 6 Post Intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients with Encephalopathy After Embolization | Count of patients who had encephalopathy after embolization. | Week 6 Post Intervention | 
| Changes in Quality of Life | Changes (noted as a score of 0 [not at all] to 4 [very much]; total score ranges from 1-180) in the different aspects of the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) quality of life questionnaire (a 45-item self-report instrument designed to measure health-related quality of life in patients with hepatobiliary cancers). | Baseline and Week 6 After Intervention | 
| Comparison of Liver Function Tests Results | List of results for alpha-fetoprotein (AFP), albumin (Alb), alanine transaminase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALKP), blood urea nitrogen (BUN), creatinine (Cr), glomerular filtration rate (GFR), Bilirubin (T, D), platelets (Plt), international normalized ratio (INR - prothrombin time), Child-Pugh score. | Day 0 and Week 6 Post Intervention | 
| Imaging Response | Determined by European Association for the Study of the Liver (EASL) criteria a set of non-invasive criteria for HCC in cirrhotic patients. The diagnosis is established if two imaging modalities (US, CT, magnetic resonance imaging (MRI)) show a coincidental nodule with arterial hypervascularization regardless of AFP levels, or if a single modality shows a lesion when the AFP levels are more than 400 ng/ml. Histologic diagnosis is required if the patient is non-cirrhotic or if the lesions are smaller than 2 cm. | Week 6 Post Intervention | 
| Number of Patients with Successful Liver Transplant |  | Week 6 After Intervention | 
| Overall Survival | Determined by date of death or date censored. | Week 6 After Intervention |