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

• overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
• progression free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

• overall survival [ Time Frame: 3 years ]
• progression free survival [ Time Frame: 3 years ]

• tumor response [ Time Frame: 4 weeks after end of treatment ] [ Designated as safety issue: No ]
• rate of conversion to resectable stage [ Time Frame: 4 weeks after end of treatment ] [ Designated as safety issue: No ]
• toxicity of treatment [ Time Frame: 4 weeks after end of treatment ] [ Designated as safety issue: Yes ]
• quality of life [ Time Frame: up to one year after randomisation ] [ Designated as safety issue: No ]
• consumption of hospital resources [ Time Frame: 3 years ] [ Designated as safety issue: No ]

• tumor response [ Time Frame: on study treatment ]
• rate of conversion to resectable stage [ Time Frame: on study treatment ]
• toxicity of treatment [ Time Frame: on study treatment ]
• quality of life [ Time Frame: up to one year after randomisation ]
• consumption of hospital resources [ Time Frame: on study treatment ]

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.

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.

• Procedure: TEA with LEM
  Transarterial ethanol ablation (TEA) with Lipiodol-ethanol mixture (LEM)
• Procedure: TACE
  Transarterial chemoembolisation (TACE)

• Experimental: 1
  TEA with LEM
  Intervention: Procedure: TEA with LEM
• Active Comparator: 2
  TACE
  Intervention: Procedure: TACE

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