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| Sponsor: | Sun Yat-sen University |
|---|---|
| Collaborator: |
Ministry of Health, China |
| Information provided by: | Sun Yat-sen University |
| ClinicalTrials.gov Identifier: | NCT00652587 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatocellular Carcinoma Hepatectomy Chemoembolization |
Procedure: hepatectomy and transcatheter arterial chemoembolization Procedure: hepatectomy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Control: Active Control Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Controlled Trial of Hepatectomy With Adjuvant Transcatheter Arterial Chemoembolization Versus Hepatectomy Alone for Stage IIIA Hepatocellular Carcinoma |
| Enrollment: | 115 |
| Study Start Date: | January 2002 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A, LRTACE: Experimental
hepatectomy with adjuvant transcatheter arterial chemoembolization
|
Procedure: hepatectomy and transcatheter arterial chemoembolization
partial hepatectomy with adjuvant transcatheter arterial chemoembolization
|
|
B, LR: Active Comparator
hepatectomy alone
|
Procedure: hepatectomy
hepatectomy alone
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
History of cardiac disease:
Excluded therapies and medications, previous and concomitant:
Contacts and Locations| China, Guangdong Province | |
| Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University | |
| Guangzhou, Guangdong Province, China, 510060 | |
| Principal Investigator: | GUO Rong-ping, MD | Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University |
More Information
| Responsible Party: | Cancer Center, Sun Yat-sen University ( Cancer Center, Sun Yat-sen University ) |
| Study ID Numbers: | HCC_001 |
| Study First Received: | March 31, 2008 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00652587 History of Changes |
| Health Authority: | China: Ministry of Health |
|
hepatocellular carcinoma hepatectomy chemoembolization randomized controlled trial prognosis |
|
Liver Neoplasms Liver Diseases Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms |
Neoplasms by Histologic Type Carcinoma, Hepatocellular Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |