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

Study Overview
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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.

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.

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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: TEA with LEM
* Procedure: TACE


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 3 years | 
| progression free survival |  | 3 years | 

Secondary Outcome Measures

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