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A Comprehensive Analysis of Clinical Outcome, Treatment Toxicity and Tumor Response of Transarterial Ablation(TEA) for Unresectable Hepatocellular Carcinoma(HCC)

Phase 2
18 Years
Open (Enrolling)
Hepatocellular Carcinoma

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Trial Information

A Comprehensive Analysis of Clinical Outcome, Treatment Toxicity and Tumor Response of Transarterial Ablation(TEA) for Unresectable Hepatocellular Carcinoma(HCC)

Transarterial therapy has been playing an important role in the treatment algorithm for
patients with multifocal or large intrahepatic lesions not eligible for surgical resection,
transplantation, or local ablative therapy. Among the various options of transarterial
therapy including chemoembolization (TACE), bland embolization, radioembolization, and TEA,
chemoembolization is the only one that has been proven to be of survival benefits versus
best supportive care in randomized controlled trials. TEA is a hybrid of bland embolization
and chemical ablation. Utilizing a liquid agent of Lipiodol-ethanol mixture consisting of
33% ethanol by volume, TEA offers complete and long lasting embolization of both the
arterioles and portal venules supplying the tumor and could possibly be more effective than
particulate embolic agents in tumor vessel embolization. The component of ethanol very
likely offers synergistic effect to embolization and causes tumor ablation.

Inclusion Criteria:

- Signed informed consent by patient

- Age above 18 years

- Child-Pugh A or B cirrhosis

- Eastern Cooperative Oncology Group performance score 2 or below

- No serious concurrent medical illness

- No prior treatment or surgery for HCC

- Histologically or cytologically proven HCC except for lesions of size 1 to 2 cm, with
typical features of HCC on two dynamic imaging techniques, or lesions larger than
2cm, with typical features on one dynamic imaging techniques, or lesions larger than
2cm with AFP level > 200 ng/mL

- Unresectable disease without extra-hepatic involvement on CXR and CT

- Massive expansive tumor type with measurable lesion on CT

- Total tumor mass < 50% liver volume

- Tumor size ≤ 15cm in largest dimension

- Tumor number ≤ 5

Exclusion Criteria:

- History of prior malignancy except on the condition that the patient has been disease
free for ≥ 3 years

- Concurrent ischemic heart disease or heart failure

- History of acute tumor rupture presenting with hemo-peritoneum

- Serum creatinine level > 180 umol/L

- Biliary obstruction not amenable to percutaneous drainage

- Child-Pugh C cirrhosis

- History of hepatic encephalopathy

- Intractable ascites not controllable by medical therapy

- History of variceal bleeding within last 3 months; serum total bilirubin level ≥ 50

- Serum albumin level < 25g/L

- INR > 1.5

- Extrahepatic metastasis

- Infiltrative or diffuse tumor

- Tumor number > 5

- Thrombosis of target hepatic artery

- Partial or complete thrombosis of the main portal vein; tumor invasion of portal
branch of contralateral lobe

- Hepatic vein tumor thrombus

- Significant arterio-portal venous shunt

- Significant arterial-hepatic venous shunt

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival and treatment-related toxicity

Outcome Description:

Overall survival was defined as date of treatment to date of death from any cause. Patients alive at the end of follow-up were censored. Clinical and laboratory data were documented prospectively at baseline, during hospitalization, and at 7, 14, and 30 day, and 3, 6, 9, and 12 months. Laboratory findings were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.

Outcome Time Frame:

Overall survival is studied from treatment to death from any cause, for an estimated period of up to 60 months. Treatment-related toxicity is studied up to 3 months after treatment

Safety Issue:


Principal Investigator

Simon CH Yu, MD, FRCR

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Imaging and Interventional Radiology, The Chinese University of Hong Kong


Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Study ID:




Start Date:

February 2007

Completion Date:

Related Keywords:

  • Hepatocellular Carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular