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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Fudan University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT01102335
First received: April 8, 2010
Last updated: April 12, 2010
Last verified: April 2010

April 8, 2010
April 12, 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01102335 on ClinicalTrials.gov Archive Site
Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
    Interventions:
    • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
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
Both
18 Years to 75 Years
No
Contact: jinglin xia, MD xia.jinglin@zs-hospital.sh.cn
Contact: biwei yang yang.biwei@zs-hospital.sh.cn
China
 
NCT01102335
LCI-001
Yes
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