Clinical trial NCT00467974: Transarterial Ethanol Ablation (TEA) Versus Transcatheter Arterial Chemoembolisation (TACE) for Hepatocellular Carcinoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2007-05-01
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: overall survival
timeFrame: 3 years
measure: progression free survival
timeFrame: 3 years
Secondary outcomes:
measure: tumor response
timeFrame: 4 weeks after end of treatment
measure: rate of conversion to resectable stage
timeFrame: 4 weeks after end of treatment
measure: toxicity of treatment
timeFrame: 4 weeks after end of treatment
measure: quality of life
timeFrame: up to one year after randomisation
measure: consumption of hospital resources
timeFrame: 3 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong
city: Hong Kong
country: Hong Kong
facility: Department of Diagnostic Radiology and Organ Imaging, Prince of Wales Hospital, The Chinese University of Hong Kong
city: Hong Kong
country: Hong Kong
facility: Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong
Study officials:
affiliation: Department of Diagnostic Radiology and Organ Imaging, Prince of Wales Hospital, The Chinese University of Hong Kong
name: Simon CH Yu, MD, FRCR
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yu SC, Hui JW, Hui EP, Chan SL, Lee KF, Mo F, Wong J, Ma B, Lai P, Mok T, Yeo W. Unresectable hepatocellular carcinoma: randomized controlled trial of transarterial ethanol ablation versus transcatheter arterial chemoembolization. Radiology. 2014 Feb;270(2):607-20. doi: 10.1148/radiol.13130498. Epub 2013 Oct 28.