Skip to main content
OpenTrials
Completed

NCT Number: NCT02650271

Adjuvant Entecavir or Tenofovir for Postoperative HBV-HCC

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University

Nanning, Guangxi, 530021, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Entecavir

Drug

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

Other names: ETV

Tenofovir

Drug

Patients will be received tenofovir before liver resection.

Primary outcomes

  1. overall survival

    Time frame: 1-year

Secondary outcomes

  1. Recurrence rate

    Time frame: 1-year

Other outcomes

  1. Perioperative reactivation of hepatitis B virus replication

    Time frame: 1-month

Sponsors and collaborators

Lead sponsor

Guangxi Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 8, 2016
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.