Know Cancer

or
forgot password

A Randomized Controlled Trial of Transarterial Ethanol Ablation (TEA) With Lipiodol-Ethanol Mixture (LEM) Versus Transcatheter Arterial Chemoembolisation (TACE) for Unresectable Hepatocellular Carcinoma


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma

Thank you

Trial Information

A Randomized Controlled Trial of Transarterial Ethanol Ablation (TEA) With Lipiodol-Ethanol Mixture (LEM) Versus Transcatheter Arterial Chemoembolisation (TACE) for Unresectable Hepatocellular Carcinoma


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

overall survival

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Simon CH Yu, MD, FRCR

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Diagnostic Radiology and Organ Imaging, Prince of Wales Hospital, The Chinese University of Hong Kong

Authority:

Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Study ID:

HCC017

NCT ID:

NCT00467974

Start Date:

June 2007

Completion Date:

June 2014

Related Keywords:

  • Hepatocellular Carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular

Name

Location