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

Primary Purpose

Hepatocellular Carcinoma

Status

Completed

Phase

Phase 3

Locations

Hong Kong

Study Type

Interventional

Intervention

TEA with LEM

TACE

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

TEA with LEM

TACE

Outcomes

Primary Outcome Measures

overall survival

progression free survival

Secondary Outcome Measures

tumor response

rate of conversion to resectable stage

toxicity of treatment

quality of life

consumption of hospital resources

Full Information

NCT ID

NCT00467974

First Posted

April 30, 2007

Last Updated

January 21, 2015

Sponsor

Chinese University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT00467974

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

June 2007 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

TEA with LEM

Arm Title

Arm Type

Active Comparator

Arm Description

TACE

Intervention Type

Procedure

Intervention Name(s)

TEA with LEM

Intervention Description

Transarterial ethanol ablation (TEA) with Lipiodol-ethanol mixture (LEM)

Intervention Type

Procedure

Intervention Name(s)

TACE

Intervention Description

Transarterial chemoembolisation (TACE)

Primary Outcome Measure Information:

Title

overall survival

Time Frame

3 years

Title

progression free survival

Time Frame

3 years

Secondary Outcome Measure Information:

Title

tumor response

Time Frame

4 weeks after end of treatment

Title

rate of conversion to resectable stage

Time Frame

4 weeks after end of treatment

Title

toxicity of treatment

Time Frame

4 weeks after end of treatment

Title

quality of life

Time Frame

up to one year after randomisation

Title

consumption of hospital resources

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Simon CH Yu, MD, FRCR

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong

City

Hong Kong

Country

Hong Kong

Facility Name

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

City

Hong Kong

Country

Hong Kong

Facility Name

Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong

City

Hong Kong

Country

Hong Kong

12. IPD Sharing Statement

Citations:

PubMed Identifier

24126369

Citation

Yu SC, Hui JW, Hui EP, Chan SL, Lee KF, Mo F, Wong J, Ma B, Lai P, Mok T, Yeo W. Unresectable hepatocellular carcinoma: randomized controlled trial of transarterial ethanol ablation versus transcatheter arterial chemoembolization. Radiology. 2014 Feb;270(2):607-20. doi: 10.1148/radiol.13130498. Epub 2013 Oct 28.

Results Reference

derived

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

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