Synergistic Treatment for Hepatocellular Carcinoma (HCC) Using Transcatheter Arterial Chemoembolization (TACE) With Anti-hepatitis B Virus (Anti-HBV) Therapy (TACEHBV)

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. Identifier: NCT01102335
Recruitment Status : Unknown
Verified April 2010 by Fudan University.
Recruitment status was:  Recruiting
First Posted : April 13, 2010
Last Update Posted : April 13, 2010
Information provided by:
Fudan University

April 8, 2010
April 13, 2010
April 13, 2010
April 2010
December 2011   (Final data collection date for primary outcome measure)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 6 months ]
Same as current
No Changes Posted
Overall survival [ Time Frame: 2 years ]
Same as current
Not Provided
Not Provided
Synergistic Treatment for Hepatocellular Carcinoma (HCC) Using Transcatheter Arterial Chemoembolization (TACE) With Anti-hepatitis B Virus (Anti-HBV) Therapy
The Observation Of Safety And Survival Of Hepatocellular Carcinoma After Transcatheter Arterial Chemoembolization Combined With Anti-hepatitis B Virus Therapy
The purpose of this study is to elucidate the influence of anti-hepatitis B virus therapy on safety and survival of HCC patient after transcatheter arterial chemoembolization.
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hepatocellular Carcinoma
  • Procedure: Transcatheter arterial chemoembolization (TACE)
    The procedure is performed under local anaesthesia. The femoral artery at groin region is punctured for arterial access. Angiography is performed for demonstration of vascular structures before embolization.The arteries supplying the tumor are selectively catheterized, this includes the hepatic arteries or other extrahepatic collateral arteries.The chemotherapeutic agent(s) is mixed with lipiodol (an oily contrast) to enhance tumour uptake. Following delivery of the lipiodol/chemotherapy mixture, small gelfoam particles may be injected to reinforce the effect of treatment.
  • Drug: Telbivudine
    anti-HBV drug
    Other Name: Sebivo
  • Experimental: Telbivudine
    • Procedure: Transcatheter arterial chemoembolization (TACE)
    • Drug: Telbivudine
  • Active Comparator: TACE only
    Intervention: Procedure: Transcatheter arterial chemoembolization (TACE)
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
December 2012
December 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • hepatocellular carcinoma
  • treated with transcatheter arterial chemoembolization (TACE)
  • HBVDNA > 10^3copies/mL, including alanine aminotransferase (ALT) normal patient
  • expected survive time > 1 year
  • HBV marker positive (anyone of HbsAg, HbsAb, HbeAg, HbeAb and HbcAb)

Exclusion Criteria:

  • antiviral therapy history
  • alanine aminotransferase (ALT) >400 U/L
  • serum total bilirubin > 50 μmol/L
  • HBVDNA > 10^9copies/mL
  • extrahepatic metastasis or main portal vein embolus
  • apparent cardiac or pulmonary dysfunction
  • liver function: Child B or Child C
  • HCV infection
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Professor Jing-lin Xia, Liver Cancer Institute
Fudan University
Not Provided
Principal Investigator: jinglin xia, MD Liver cancer institute, Zhongshan Hospital
Fudan University
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP