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

Hepatocellular Carcinoma Clinical Trial

— TACEHBV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01102335
• Other study ID #: LCI-001
• Status: Recruiting
• Phase: Phase 4
• First received: April 8, 2010
• Last updated: April 12, 2010
• Start date: April 2010
• Est. completion date: December 2012

Study information

• Verified date: April 2010
• Source: Fudan University
• Contact: jinglin xia, MD
• Email: xia.jinglin[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatitis B
• Hepatocellular Carcinoma

Intervention

Procedure:
• 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.

Drug:
• Telbivudine
anti-HBV drug

Locations

Country	Name	City	State
China	Liver cancer institute, Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		6 months	Yes
Secondary	Overall survival		2 years	Yes