Chemoembolization With or Without Antiviral Therapy for Unresectable HBV-related HCC With Low HBV DNA Replication
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01894269|
Recruitment Status : Unknown
Verified July 2013 by Xiang-Ming Lao, Sun Yat-sen University.
Recruitment status was: Recruiting
First Posted : July 10, 2013
Last Update Posted : July 23, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: Lamivudine 100mg once daily; or Entecavir 0.5mg once daily.||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||July 2016|
Experimental: Anti-viral treatment
Oral antiviral drugs will be commenced after TACE. That is: Lamivudine 100mg once daily; or Entecavir 0.5mg once daily.
Drug: Lamivudine 100mg once daily; or Entecavir 0.5mg once daily.
In experimental group, Lamivudine 100mg once daily; or Entecavir 0.5mg once daily will be commenced after TACE.
No Intervention: Control
No anti-viral therapy after TACE.
- overall survival [ Time Frame: 1 year ]
- HBV reactivation [ Time Frame: 1 year ]
- HBV resistance to lamivudine or entecavir [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01894269
|Contact: Xiang-Ming Lao, MDemail@example.com|
|Contact: Xiao-Jun Lin, MDfirstname.lastname@example.org|
|Sun Yat-sen University Cancer Center||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Xiang-Ming Lao, MD 8620-87343114 email@example.com|
|Principal Investigator:||Xiao-Jun Lin, MD||Sun Yat-sen University|
|Principal Investigator:||Xiang-Ming Lao, MD||Sun Yat-sen University|