Adjuvant Entecavir or Tenofovir for Postoperative HBV-HCC

January 21, 2024 updated by: Jian-Hong Zhong, Guangxi Medical University

Adjuvant Entecavir or Tenofovir for Hepatitis B Virus Related Hepatocellular Carcinoma After Curative Hepatic Resection

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Exclusion Criteria:

  • Anti-HCV(+)
  • Diagnosis of HCC was not confirmed by postoperative histopathology of surgical samples after surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Entecavir
Patients will be received entecavir (10 mg/d) after 3 days of liver resection.
Drug: Entecavir
Patients will be received entecavir (10 mg/d) before liver resection.
Other Names:
  • ETV
Active Comparator: Tenofovir
Patients will be received tenofovir (1#/d) after 3 days of liver resection.
Drug: Tenofovir
Patients will be received tenofovir before liver resection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 1-year
1-year

Secondary Outcome Measures

Outcome Measure
Time Frame
Recurrence rate
Time Frame: 1-year
1-year

Other Outcome Measures

Outcome Measure
Time Frame
Perioperative reactivation of hepatitis B virus replication
Time Frame: 1-month
1-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangxi Medical University

Investigators

  • Study Chair: Le-Qun Li, MD, Guangxi Medical University Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2021

Primary Completion (Actual)

December 25, 2023

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

January 5, 2016

First Submitted That Met QC Criteria

January 7, 2016

First Posted (Estimated)

January 8, 2016

Study Record Updates

Last Update Posted (Estimated)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 21, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEVT-HCC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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