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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01102335

Acronym

TACEHBV

Enrollment

Registered

2010-04-13

Start date

2010-04-30

Completion date

2012-12-31

Last updated

2010-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

hepatitis B virus, Antiviral Agents, Liver Neoplasms, Drug Toxicity, Survival

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.

Interventions

PROCEDURETranscatheter 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.

DRUGTelbivudine

anti-HBV drug

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	6 months

Secondary

Measure	Time frame
Overall survival	2 years

Countries

China

Contacts

Primary Contactjinglin xia, MD

xia.jinglin@zs-hospital.sh.cn

Backup Contactbiwei yang

yang.biwei@zs-hospital.sh.cn

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026