A Randomized Controlled Trial of Hepatectomy With Adjuvant Transcatheter Arterial Chemoembolization Versus Hepatectomy Alone for Stage IIIA Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) is one of the most common malignancies in the world, and the
prevalence is increasing in the United States. Hepatectomy is still considered as the
potentially curative treatment for HCC. Unfortunately, long-term survival after hepatectomy
is still unsatisfactory because of the high incidence of tumor recurrence, especially
intrahepatic recurrence.
Stage IIIA hepatocellular carcinoma (HCC) include multiple tumors more than 5 cm or tumor
involving a major branch of the portal or hepatic vein(s) in the International Union Against
Cancer (UICC) TNM staging for liver tumors, sixth edition 2002. Until now there are
controversies in the management of Stage IIIA HCC. According to the Barcelona
-Clinic-Liver-Cancer (BCLC) proposal, Stage IIIA HCC represented as intermediate or advanced
disease. The European Association for Study of the Liver (EASL) and the American Association
for the Study of Liver Diseases (AASLD) recommended randomized controlled trials of
chemoembolization or new agents for such stage of disease. Whereas in Asian areas, such as
China or Japan, partial hepatectomy or reductive surgery (with or without adjuvant therapy)
was performed for multiple advanced HCC or tumor with a major branch of the portal or
hepatic vein(s) invasion, although no prospective study to assess the therapeutic efficacy
and safety. On the other hand, transcatheter arterial chemoembolization (TACE) is the most
widely used primary treatment for unresectable HCC. It was also used as the optional
treatment of relapsed disease. However, the efficacy of TACE used as adjuvant therapy
following hepatectomy remains controversial. Neither are there large randomized controlled
trials to address this field. Therefore, a randomized controlled trial was performed in our
cancer center to compare hepatectomy with adjuvant TACE and hepatectomy alone for the Stage
IIIA HCC.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
overall survival rates
1-, 3-, and 5-year
No
GUO Rong-ping, MD
Principal Investigator
Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University
China: Ministry of Health
HCC_001
NCT00652587
January 2002
December 2007
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