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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
Fudan University

Tracking Information
First Submitted Date  ICMJE April 8, 2010
First Posted Date  ICMJE April 13, 2010
Last Update Posted Date April 13, 2010
Study Start Date  ICMJE April 2010
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2010)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2010)
Overall survival [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Synergistic Treatment for Hepatocellular Carcinoma (HCC) Using Transcatheter Arterial Chemoembolization (TACE) With Anti-hepatitis B Virus (Anti-HBV) Therapy
Official Title  ICMJE The Observation Of Safety And Survival Of Hepatocellular Carcinoma After Transcatheter Arterial Chemoembolization Combined With Anti-hepatitis B Virus Therapy
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatocellular Carcinoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Telbivudine
    Interventions:
    • Procedure: Transcatheter arterial chemoembolization (TACE)
    • Drug: Telbivudine
  • Active Comparator: TACE only
    Intervention: Procedure: Transcatheter arterial chemoembolization (TACE)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 12, 2010)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2012
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01102335
Other Study ID Numbers  ICMJE LCI-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Professor Jing-lin Xia, Liver Cancer Institute
Study Sponsor  ICMJE Fudan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: jinglin xia, MD Liver cancer institute, Zhongshan Hospital
PRS Account Fudan University
Verification Date April 2010

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