Back to resultsSynergistic Treatment for Hepatocellular Carcinoma (HCC) Using Transcatheter Arterial Chemoembolization (TACE) With Anti-hepatitis B Virus (Anti-HBV) Therapy (TACEHBV)
Primary Purpose
Hepatocellular Carcinoma
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Transcatheter arterial chemoembolization (TACE)
Telbivudine
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hepatitis B virus, Antiviral Agents, Liver Neoplasms, Drug Toxicity, Survival
Eligibility 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
Sites / Locations
- Liver cancer institute, Zhongshan Hospital, Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Telbivudine
TACE only
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Secondary Outcome Measures
Overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01102335
Brief Title
Synergistic Treatment for Hepatocellular Carcinoma (HCC) Using Transcatheter Arterial Chemoembolization (TACE) With Anti-hepatitis B Virus (Anti-HBV) Therapy
Acronym
TACEHBV
Official Title
The Observation Of Safety And Survival Of Hepatocellular Carcinoma After Transcatheter Arterial Chemoembolization Combined With Anti-hepatitis B Virus Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
hepatitis B virus, Antiviral Agents, Liver Neoplasms, Drug Toxicity, Survival
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Telbivudine
Arm Type
Experimental
Arm Title
TACE only
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Transcatheter arterial chemoembolization (TACE)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Telbivudine
Other Intervention Name(s)
Sebivo
Intervention Description
anti-HBV drug
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jinglin xia, MD
Email
xia.jinglin@zs-hospital.sh.cn
First Name & Middle Initial & Last Name or Official Title & Degree
biwei yang
Email
yang.biwei@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jinglin xia, MD
Organizational Affiliation
Liver cancer institute, Zhongshan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liver cancer institute, Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jinglin xia, MD
First Name & Middle Initial & Last Name & Degree
jinglin xia, MD
12. IPD Sharing Statement
Learn more about this trial
Synergistic Treatment for Hepatocellular Carcinoma (HCC) Using Transcatheter Arterial Chemoembolization (TACE) With Anti-hepatitis B Virus (Anti-HBV) Therapy
We'll reach out to this number within 24 hrs