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

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00467974
• Other study ID #: HCC017
• Status: Completed
• Phase: Phase 3
• First received: April 30, 2007
• Last updated: January 21, 2015
• Start date: June 2007
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

Locations

Country	Name	City	State
Hong Kong	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

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		3 years	No
Primary	progression free survival		3 years	No
Secondary	tumor response		4 weeks after end of treatment	No
Secondary	rate of conversion to resectable stage		4 weeks after end of treatment	No
Secondary	toxicity of treatment		4 weeks after end of treatment	Yes
Secondary	quality of life		up to one year after randomisation	No
Secondary	consumption of hospital resources		3 years	No