drugset / Trial / NCT01894269

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

NCT01894269

Phase 4 Unknown 200 enrolled Sun Yat-sen University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2013-07
Primary completion
2015-07
Completion
2016-07

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Entecavir Small molecule 0.5 mg Oral
Subject Lamivudine Other / unclassified 100 mg Oral