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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Drug: Drug-Eluting Beads (DEB) with Doxorubicin; Drug: Lipiodol Ethanol Mixture

Detailed Description

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Masonic Cancer Center, University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Drug-Eluting Beads with Doxorubicin; 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; 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).; Other Names: Doxorubicin
ACTIVE_COMPARATOR: Lipiodol Ethanol Mixture (LEM); 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; 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).; Other Names: LEM

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Erik Cressman, M.D., Masonic Cancer Center, University of Minnesota

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: December 6, 2011
• First Submitted That Met QC Criteria: December 7, 2011
• First Posted (ESTIMATE): December 9, 2011

Study Record Updates

• Last Update Posted (ACTUAL): August 31, 2017
• Last Update Submitted That Met QC Criteria: August 30, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Ethanol; Doxorubicin; Liposomal doxorubicin; Ethiodized Oil
• Other Study ID Numbers: 2011LS117