Entecavir for Chronic Hepatitis B in Hepatocellular Carcinoma Patients Underwent Radiofrequency Ablation Therapy

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

Total Enrollment

420 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Brief Summary

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

Persistent replication of HBV (47-55%) is frequently found in patients with HCC, which in turn leads to deterioration of liver reserve. Moreover, a large proportion of HCC patients who underwent curative therapy died from progressive liver decompensation rather than recurrence of cancer. It had been proved that anti-viral therapy for hepatitis C virus (HCV)-related HCC patients could reduce the rate of tumor recurrence after surgical resection.

This is a prospective study to evaluate the efficacy of ETV therapy in chronic hepatitis B patients after receiving RFA therapy for HCC.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Entecavir for Chronic Hepatitis B Patients With Persistently Normal ALT

NCT01833611

Chronic Hepatitis

UNKNOWN PHASE4

Prophylactic Antiviral Therapy in Patients With Current or Past Hepatitis B Virus Infection Receiving Anti-Cancer Therapy for Solid Tumors

NCT03887702

Hepatitis B Infection Malignant Solid Neoplasm

TERMINATED PHASE3

Comparison of the Efficacy of Entecavir and Tenofovir Monotherapy for the Treatment of Nucleos(t)Ide-naïve Patients With Chronic Hepatitis B in Korea

NCT01776814

Chronic Hepatitis B

UNKNOWN

Risk of Hepatocellular Carcinoma in Patients Treated With ETV vs TDF for Chronic Hepatitis B With Compensated Cirrhosis

NCT04160897

Hepatitis B, Chronic Hepatocellular Carcinoma Compensated Cirrhosis

UNKNOWN

Effect of Entecavir Treatment on Regression and Disease Outcome in HBV-induced Liver Fibrosis and Cirrhosis Patients

NCT02849132

Hepatitis B Liver Cirrhosis

ACTIVE_NOT_RECRUITING PHASE4

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.

Chronic Hepatitis B Hepatocellular Carcinoma

Study Design

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

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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

Entecavir

Intervention Type DRUG

film coated tablets / 0.5mg / once daily / 3 years

Interventions

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

Entecavir

film coated tablets / 0.5mg / once daily / 3 years

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* HCC diagnosed by pathology verification or in accordance with the guidelines of American Association for the Study of Liver Diseases published in 2010 (typical vascular pattern in computed tomography scan or magnetic resonance imaging study) ,
* Solitary tumor less than 5 cm in diameter or 2-3 tumors with the largest one no more than 3 cm in diameter,
* No extrahepatic metastasis,
* No radiological evidence of invasion into major portal vein or hepatic vein branches,
* Good liver reserve with Child-Pugh Class A or B,
* A platelet count of more than 50,000/mm3,
* Serum creatinine level ≤ 2 mg/dL,
* No previous treatment for HCC,
* Positive for serum hepatitis B surface antigen (HBsAg) for more than 6 months
* Positive serum HBV DNA using a Cobas Amplicor HBV monitor (Roche Diagnostic System, Basel, Switzerland).

Exclusion Criteria

* Dual or multiple infections with hepatitis C virus, hepatitis D virus, or the human immunodeficiency virus,
* Other forms of liver disease such as alcoholic hepatitis, autoimmune hepatitis, Wilson's disease, hemochromatosis,
* Use of interferon alpha, thymosin or antiviral agents within 6 months preceding entry into the study,
* Women who are pregnant or nursing.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No