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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
overall survival and treatment-related toxicity
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.
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
No
Simon CH Yu, MD, FRCR
Principal Investigator
Department of Imaging and Interventional Radiology, The Chinese University of Hong Kong
Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
VIR-13-03
NCT01837381
February 2007
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