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

NCT ID: NCT01102335

Last Updated: 2010-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatocellular Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Telbivudine

Group Type EXPERIMENTAL

Transcatheter arterial chemoembolization (TACE)

Intervention Type PROCEDURE

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.

Telbivudine

Intervention Type DRUG

anti-HBV drug

TACE only

Group Type ACTIVE_COMPARATOR

Transcatheter arterial chemoembolization (TACE)

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Telbivudine

anti-HBV drug

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Sebivo

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fudan University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Liver Cancer Institute

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

jinglin xia, MD

Role: PRINCIPAL_INVESTIGATOR

Liver cancer institute, Zhongshan Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Liver cancer institute, Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

jinglin xia, MD

Role: CONTACT

biwei yang

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

jinglin xia, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LCI-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.