Synergistic Treatment for Hepatocellular Carcinoma (HCC) Using Transcatheter Arterial Chemoembolization (TACE) With Anti-hepatitis B Virus (Anti-HBV) Therapy
NCT ID: NCT01102335
Last Updated: 2010-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
80 participants
INTERVENTIONAL
2010-04-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Telbivudine
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.
Telbivudine
anti-HBV drug
TACE only
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.
Interventions
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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.
Telbivudine
anti-HBV drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Liver Cancer Institute
Principal Investigators
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jinglin xia, MD
Role: PRINCIPAL_INVESTIGATOR
Liver cancer institute, Zhongshan Hospital
Locations
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Liver cancer institute, Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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jinglin xia, MD
Role: primary
Other Identifiers
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LCI-001
Identifier Type: -
Identifier Source: org_study_id
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