NCT00652587

Hepatectomy With or Without Transcatheter Arterial Chemoembolization for Stage IIIA Hepatocellular Carcinoma

A Randomized Controlled Trial of Hepatectomy With Adjuvant Transcatheter Arterial Chemoembolization Versus Hepatectomy Alone for Stage IIIA Hepatocellular Carcinoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate whether hepatectomy combining with adjuvant transcatheter arterial chemoembolization (TACE) for Stage IIIA hepatocellular carcinoma (HCC) resulting better long-term survival outcome when compared with hepatectomy alone.

Detailed description

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.

Conditions

• Hepatocellular Carcinoma
• Hepatectomy
• Chemoembolization

Interventions

Type	Name	Description
PROCEDURE	hepatectomy and transcatheter arterial chemoembolization	partial hepatectomy with adjuvant transcatheter arterial chemoembolization
PROCEDURE	hepatectomy	hepatectomy alone

Timeline

• Start date: 2002-01-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2008-04-03
• Last updated: 2008-04-03

Locations

1 site across 1 country: China