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

Phase 3

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: TACE; Procedure: TEA with LEM

• Registration Number: NCT00467974
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study First Submitted: 2007-04-30
• Study First Submitted QC: 2007-04-30
• Study First Posted: 2007-05-01
• Study Start: 2007-06
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2014-12
• Last Update Submitted: 2015-01-21
• Last Update Posted: 2015-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	TACE	TACE
1	TEA with LEM	TEA with LEM

Primary Outcome Measures

Name	Time	Method
progression free survival	3 years
overall survival	3 years

Secondary Outcome Measures

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

Trial Locations

Locations (3)

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; 🇭🇰 Hong Kong, Hong Kong