Synergistic Treatment for Hepatocellular Carcinoma (HCC) Using Transcatheter Arterial Chemoembolization (TACE) With Anti-hepatitis B Virus (Anti-HBV) Therapy

Study Overview
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Brief Summary
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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.

Official Title
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The Observation Of Safety And Survival Of Hepatocellular Carcinoma After Transcatheter Arterial Chemoembolization Combined With Anti-hepatitis B Virus Therapy

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: Transcatheter arterial chemoembolization (TACE)
* Drug: Telbivudine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telbivudine<br> | Procedure: Transcatheter arterial chemoembolization (TACE)<br>* 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.<br>Drug: Telbivudine<br>* anti-HBV drug<br>* Other names: Sebivo;|
| Active Comparator: TACE only<br> | Procedure: Transcatheter arterial chemoembolization (TACE)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatitis B virus, Antiviral Agents, Liver Neoplasms, Drug Toxicity, Survival