Chemoembolization With or Without Antiviral Therapy for Unresectable HBV-related HCC With Low HBV DNA Replication

Hepatocellular Carcinoma Clinical Trial

Official title: Chemoembolization With or Without Antiviral Therapy for Unresectable HBV-related Hepatocellular Carcinoma With Low HBV DNA Replication: Effectiveness and Safety. A Prospective and Randomized Clinical Trial

Status Recruiting

Clinical Trial Summary

Although it is commonly accepted that antiviral therapy should be commenced before or during hepatocellular carcinoma (HCC) treatment if the patients have high viral loads and elevated ALT or total bilirubin values with signs of cirrhosis, the dilemma exists when HBV DNA and liver function (such as ALT, AST, TBIL) remains low level. Whether antiviral therapy make sense or not in these patients with no signs of hepatitis or high viral replication remains unclear, especially for the relatively advanced stage HCC patients receiving TACE. Thus, the investigators carried out this prospective control study to compare the survivals for patients after TACE between with or without antiviral therapy.

Clinical Trial Description

In highly endemic areas, hepatitis B virus (HBV) infection plays a primary role in the etiology of HCC and is frequently observed in HCC patients. Patients with HBV-related HCC usually have a history of chronic HBV infection. Chemotherapy for other malignancies has been associated with HBV reactivation. Furthermore, in end stage liver disease due to HBV, levels of HBV replication have been correlated with liver function. For TACE, reports on HBV reactivation have been inconsistent. Some studies have demonstrated HBV reactivation, some have not , and others have shown decreased HBV DNA levels . The exact mechanism by which this occurs is still unknown. Although anti-HBV therapy has been reported to suppress HBV reactivation in various clinical settings with immunosuppressive conditions, few reports were concerned with the TACE treatment of HBV-related HCC. Also, the long-term effects of antiviral therapy in relatively advanced HCC patients after HCC remains unclear.

Although it is commonly accepted that antiviral therapy should be commenced before or during HCC treatment if the patients have high viral loads and elevated ALT or total bilirubin values with signs of cirrhosis, the dilemma exists when HBV DNA and liver function (such as ALT, AST, TBIL) remains low level. Therefore, we would call for the establishment of clinical practice guidelines on the antiviral therapy in HBV-related HCC patients, especially a consensus on the indications to administer nucleosides analogs (NAs).

Thus , the purpose of the investigators' study is to prospectively study the efficacy of nucleosides analogs (NAs) in transcatheter arterial chemoembolization for nonresectable hepatocellular carcinoma with relatively low HBV DNA replication and Child-Pugh grade A based on multivariate analysis of prognostic factors. The HBV DNA and liver function parameters will be monitored closely. Once the reactivation occurs in the control group, antiviral therapy would be administered immediately. The study had a interim analysis to allow the trial to be stopped if significant differences were detected. The accumulated data were examined when half patient was enrolled in the clinical trial. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

• NCT number: NCT01894269
• Study type: Interventional
• Source: Sun Yat-sen University
• Contact: Xiang-Ming Lao, MD
• Phone: 8620-87343114
• Email: laoxming@mail.sysu.edu.cn
• Status: Recruiting
• Phase: Phase 4
• Start date: July 2013
• Completion date: July 2016