Synergistic Treatment for Hepatocellular Carcinoma (HCC) Using Transcatheter Arterial Chemoembolization (TACE) With Anti-hepatitis B Virus (Anti-HBV) Therapy
Phase 4
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Procedure: Transcatheter arterial chemoembolization (TACE)
- Registration Number
- NCT01102335
- Lead Sponsor
- Fudan University
- 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 available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telbivudine Transcatheter arterial chemoembolization (TACE) - TACE only Transcatheter arterial chemoembolization (TACE) - Telbivudine Telbivudine -
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events as a Measure of Safety and Tolerability 6 months
- Secondary Outcome Measures
Name Time Method Overall survival 2 years
Trial Locations
- Locations (1)
Liver cancer institute, Zhongshan Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China