Synergistic Treatment for Hepatocellular Carcinoma (HCC) Using Transcatheter Arterial Chemoembolization (TACE) With Anti-hepatitis B Virus (Anti-HBV) Therapy
TACEHBV
The Observation Of Safety And Survival Of Hepatocellular Carcinoma After Transcatheter Arterial Chemoembolization Combined With Anti-hepatitis B Virus Therapy
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 hepatocellular-carcinoma
Started Apr 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 8, 2010
CompletedFirst Posted
Study publicly available on registry
April 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedApril 13, 2010
April 1, 2010
1.7 years
April 8, 2010
April 12, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
6 months
Secondary Outcomes (1)
Overall survival
2 years
Study Arms (2)
Telbivudine
EXPERIMENTALTACE only
ACTIVE COMPARATORInterventions
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 Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Liver cancer institute, Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
jinglin xia, MD
Liver cancer institute, Zhongshan Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 8, 2010
First Posted
April 13, 2010
Study Start
April 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2012
Last Updated
April 13, 2010
Record last verified: 2010-04