Overview

This trial is active, not recruiting.

Condition hepatocellular carcinoma
Treatments tea with lem, tace
Phase phase 3
Sponsor Chinese University of Hong Kong
Start date June 2007
End date June 2015
Trial size 200 participants
Trial identifier NCT00467974, HCC017

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
TEA with LEM
tea with lem
Transarterial ethanol ablation (TEA) with Lipiodol-ethanol mixture (LEM)
(Active Comparator)
TACE
tace
Transarterial chemoembolisation (TACE)

Primary Outcomes

Measure
overall survival
time frame: 3 years
progression free survival
time frame: 3 years

Secondary Outcomes

Measure
tumor response
time frame: 4 weeks after end of treatment
rate of conversion to resectable stage
time frame: 4 weeks after end of treatment
toxicity of treatment
time frame: 4 weeks after end of treatment
quality of life
time frame: up to one year after randomisation
consumption of hospital resources
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Simon CH Yu, MD, FRCR
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Chinese University of Hong Kong.