Transarterial Ethanol Ablation (TEA) Versus Transcatheter Arterial Chemoembolisation (TACE) for Hepatocellular Carcinoma

January 21, 2015 updated by: Edwin P Hui, Chinese University of Hong Kong

A Randomized Controlled Trial of Transarterial Ethanol Ablation (TEA) With Lipiodol-Ethanol Mixture (LEM) Versus Transcatheter Arterial Chemoembolisation (TACE) for Unresectable Hepatocellular Carcinoma

The current randomized controlled trial comparing LEM and TACE aims to evaluate the safety and efficacy of LEM as compared to TACE for treating patients with unresectable HCC.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The standard loco-regional treatment for unresectable hepatocellular carcinoma is transarterial chemoembolization (TACE). However, The drawback of conventional chemoembolization (TACE) for liver cancer is that it cannot effectively embolize portal venules supplying the tumors, therefore chemoembolization is difficult to completely eradicate the tumor. Usually multiple treatments are required and tumor recurrences are common.

Transarterial Ethanol Ablation (LEM) can potentially provide a better treatment outcome with fewer treatment sessions. Preliminary results from a clinical study showed that the complication rate is reduced while survival rate may be improved. This study aims to compare survival duration and response rate between the treatments TACE and LEM.

Study Type

Interventional

Enrollment (Anticipated)

98

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong
      • Hong Kong, Hong Kong
        • Department of Diagnostic Radiology and Organ Imaging, Prince of Wales Hospital, The Chinese University of Hong Kong
      • Hong Kong, Hong Kong
        • Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patient factor

  • Age > 18
  • Child-Pugh A or B cirrhosis
  • ECOG performance status Grade 2 or below
  • No serious concurrent medical illness
  • No prior treatment (including surgery) for HCC

Tumor factor

  • Histologically or cytologically proven HCC (an alphafetoprotein level > 500 ug/ml in the presence of radiological findings suggestive of HCC in a patient with chronic HBV or HCV infection can be considered eligible at investigator's discretion)
  • Unresectable and locally advanced disease without extra-hepatic disease
  • Massive expansive or nodular tumor morphology with measurable lesion on CT
  • Size of largest tumor <= 15cm in largest dimension
  • Number of main tumor <= 5, excluding associated small satellite lesions.

Exclusion Criteria:

Patient factor

  • History of prior malignancy except skin cancer
  • History of significant concurrent medical illness such as ischemic heart disease or heart failure
  • History of acute tumor rupture
  • Serum creatinine level > 180 umol/L
  • Presence of biliary obstruction not amenable to percutaneous drainage
  • Child-Pugh C cirrhosis

Evidence of poor liver function

  • History of hepatic encephalopathy, or
  • Intractable ascites not controllable by medical therapy, or
  • History of variceal bleeding within last 3 months, or
  • Serum total bilirubin level > 50 umol/L, or
  • Serum albumin level < 28g/L, or
  • INR > 1.3

Tumor factor

  • Presence of extrahepatic metastasis
  • Predominantly infiltrative lesion
  • Diffuse tumor morphology with extensive lesions involving both lobes.

Vascular complications

  • Hepatic artery thrombosis, or
  • Partial or complete thrombosis of the main portal vein, or
  • Tumor invasion of portal branch of contralateral lobe, or
  • Hepatic vein tumor thrombus, or
  • Significant arterioportal shunt not amenable to shunt blockage, or
  • Significant arteriovenous shunt not amenable to shunt blockage

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
TEA with LEM
Procedure: TEA with LEM
Transarterial ethanol ablation (TEA) with Lipiodol-ethanol mixture (LEM)
Active Comparator: 2
TACE
Procedure: TACE
Transarterial chemoembolisation (TACE)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 3 years
3 years
progression free survival
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
tumor response
Time Frame: 4 weeks after end of treatment
4 weeks after end of treatment
rate of conversion to resectable stage
Time Frame: 4 weeks after end of treatment
4 weeks after end of treatment
toxicity of treatment
Time Frame: 4 weeks after end of treatment
4 weeks after end of treatment
quality of life
Time Frame: up to one year after randomisation
up to one year after randomisation
consumption of hospital resources
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Simon CH Yu, MD, FRCR, Department of Diagnostic Radiology and Organ Imaging, Prince of Wales Hospital, The Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

April 30, 2007

First Submitted That Met QC Criteria

April 30, 2007

First Posted (Estimate)

May 1, 2007

Study Record Updates

Last Update Posted (Estimate)

January 26, 2015

Last Update Submitted That Met QC Criteria

January 21, 2015

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCC017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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