Status:
COMPLETED
Transarterial Ethanol Ablation (TEA) Versus Transcatheter Arterial Chemoembolisation (TACE) for Hepatocellular Carcinoma
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Detailed Description
The standard loco-regional treatment for unresectable hepatocellular carcinoma is transarterial chemoembolization (TACE). However, The drawback of conventional chemoembolization (TACE) for liver cance...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2014
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00467974
Start Date
June 1 2007
End Date
November 1 2014
Last Update
January 26 2015
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong, Hong Kong
2
Department of Diagnostic Radiology and Organ Imaging, Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong, Hong Kong
3
Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong, Hong Kong