Adjuvant Entecavir or Tenofovir for Postoperative HBV-HCC

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-02

Study Completion Date

2023-12-30

Brief Summary

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

This study aims to compare the effect of antiviral therapy with entecavir or tenofovir for hepatitis B virus-related hepatocellular carcinoma after radical hepatectomy. Included patients will randomly divide into two groups.

Related Clinical Trials

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

A RCT of TNF and ENT in the Treatment of Long-term Prognosis With Hepatitis B-related HCC After Curative Resection

NCT04392700

Hepatocellular Carcinoma Recurrent

UNKNOWN PHASE3

Antiviral Therapy for Patients With Liver Cancer After Surgery

NCT05466565

Hepatocellular Carcinoma

RECRUITING

RCT of Different Effects of Nucleot(s)Ide Analogues on the Prognosis of HBV-HCC Patients After Curative Resection

NCT04032860

HCC HBV Coinfection

ACTIVE_NOT_RECRUITING PHASE4

Efficacy of Antiviral Therapy After Radical Resection for Hepatitis B Virus-Related Hepatocellular Carcinoma

NCT00768157

Hepatocellular Carcinoma Hepatitis B Virus Recurrence

UNKNOWN PHASE4

TAF Monotherapy Versus ETV Combined With TAF on the Efficacy and Prognosis of Immunotherapy for Hepatitis B-Related Hepatocellular Carcinoma

NCT07253220

Hepatitis B Hepatocellular Carcinoma (HCC)

NOT_YET_RECRUITING NA

Detailed Description

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

Hepatocellular carcinoma (HCC) is associated with a poor prognosis, and its incidence has increased dramatically in many countries. Hepatectomy is a radical therapy for early-stage HCC. However, even after radical resection, the prognosis for HCC patients remains discouraging because of the high recurrence rate and frequent incidence of intrahepatic metastasis. Therefore, preventing HCC recurrence is very important.

Hepatitis B virus (HBV) infection is the major risk factor for HCC development in China. Some retrospective studies have shown that tenofovir or entecavir treatment for HBV-related HCC patients can effectively reduce the HCC recurrence rate and increase the survival rate after hepatectomy. However, which drug has more efficacy has not been addressed.

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

DOUBLE

Participants Caregivers

Study Groups

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

Entecavir

Patients will be received entecavir (10 mg/d) after 3 days of liver resection.

Group Type EXPERIMENTAL

Entecavir

Intervention Type DRUG

Patients will be received entecavir (10 mg/d) before liver resection.

Tenofovir

Patients will be received tenofovir (1#/d) after 3 days of liver resection.

Group Type ACTIVE_COMPARATOR

Tenofovir

Intervention Type DRUG

Patients will be received tenofovir before liver resection.

Interventions

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

Entecavir

Patients will be received entecavir (10 mg/d) before liver resection.

Intervention Type DRUG

Tenofovir

Patients will be received tenofovir before liver resection.

Intervention Type DRUG

Other Intervention Names

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

ETV

Eligibility Criteria

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

Inclusion Criteria

* Underwent hepatic resection.
* Diagnosis of HCC was confirmed by postoperative histopathology.
* Positive of HBsAg, HBeAg, or HBV DNA.
* Child-Pugh A or B liver function.