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

Fudan University logo

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)

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)

Trial contacts and locations

1

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Central trial contact

biwei yang; jinglin xia, MD

Data sourced from clinicaltrials.gov

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