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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2014-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

TEA with LEM

Group Type EXPERIMENTAL

TEA with LEM

Intervention Type PROCEDURE

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

2

TACE

Group Type ACTIVE_COMPARATOR

TACE

Intervention Type PROCEDURE

Transarterial chemoembolisation (TACE)

Interventions

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TEA with LEM

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

Intervention Type PROCEDURE

TACE

Transarterial chemoembolisation (TACE)

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No