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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. The completion date has passed and the status has not been verified in more than two years.
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
  Purpose
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.

Condition Intervention Phase
Hepatocellular Carcinoma Procedure: Transcatheter arterial chemoembolization (TACE) Drug: Telbivudine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Observation Of Safety And Survival Of Hepatocellular Carcinoma After Transcatheter Arterial Chemoembolization Combined With Anti-hepatitis B Virus Therapy

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 2 years ]

Estimated Enrollment: 80
Study Start Date: April 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telbivudine 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
Active Comparator: TACE only 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01102335

Contacts
Contact: jinglin xia, MD xia.jinglin@zs-hospital.sh.cn
Contact: biwei yang yang.biwei@zs-hospital.sh.cn

Locations
China, Shanghai
Liver cancer institute, Zhongshan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: jinglin xia, MD         
Principal Investigator: jinglin xia, MD         
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: jinglin xia, MD Liver cancer institute, Zhongshan Hospital
  More Information

Responsible Party: Professor Jing-lin Xia, Liver Cancer Institute
ClinicalTrials.gov Identifier: NCT01102335     History of Changes
Other Study ID Numbers: LCI-001
Study First Received: April 8, 2010
Last Updated: April 12, 2010

Keywords provided by Fudan University:
hepatitis B virus
Antiviral Agents
Liver Neoplasms
Drug Toxicity
Survival

Additional relevant MeSH terms:
Carcinoma
Hepatitis
Carcinoma, Hepatocellular
Hepatitis B
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Diseases
Digestive System Diseases
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Telbivudine
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 21, 2017