Adjuvant Entecavir or Tenofovir for Postoperative HBV-HCC

Phase 3

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Entecavir; Drug: Tenofovir

• Registration Number: NCT02650271
• Lead Sponsor: Guangxi Medical University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2016-01-05
• Study First Submitted QC: 2016-01-07
• Study First Posted: 2016-01-08
• Study Start: 2021-02-02
• Primary Completion: 2023-12-25
• Study Completion: 2023-12-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-21
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Entecavir	Entecavir	Patients will be received entecavir (10 mg/d) after 3 days of liver resection.
Tenofovir	Tenofovir	Patients will be received tenofovir (1#/d) after 3 days of liver resection.

Primary Outcome Measures

Name	Time	Method
overall survival	1-year

Secondary Outcome Measures

Name	Time	Method
Recurrence rate	1-year

Trial Locations

Locations (1)

Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University; 🇨🇳 Nanning, Guangxi, China