ClinicalTrials.Veeva

Menu

Adjuvant Entecavir or Tenofovir for Postoperative HBV-HCC

G

Guangxi Medical University

Status and phase

Completed
Phase 3

Conditions

Hepatocellular Carcinoma

Treatments

Drug: Entecavir
Drug: Tenofovir

Study type

Interventional

Funder types

Other

Identifiers

NCT02650271
AEVT-HCC

Details and patient eligibility

About

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.

Full 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.

Enrollment

240 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

240 participants in 2 patient groups

Entecavir
Experimental group
Description:
Patients will be received entecavir (10 mg/d) after 3 days of liver resection.
Treatment:
Drug: Entecavir
Tenofovir
Active Comparator group
Description:
Patients will be received tenofovir (1#/d) after 3 days of liver resection.
Treatment:
Drug: Tenofovir

Trial contacts and locations

1

Loading...

Central trial contact

Jian-Hong Zhong, MD; Liang Ma, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems