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

Fudan University

Status and phase: Unknown; Phase 4

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Telbivudine; Procedure: Transcatheter arterial chemoembolization (TACE)

Study type: Interventional

Funder types: Other

Identifiers

NCT01102335

LCI-001

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Telbivudine

Experimental group

Treatment:

Procedure: Transcatheter arterial chemoembolization (TACE)

Drug: Telbivudine

TACE only

Active Comparator group

Treatment:

Procedure: Transcatheter arterial chemoembolization (TACE)