NCT02650271

Adjuvant Entecavir or Tenofovir for Postoperative HBV-HCC

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Guangxi Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Entecavir	Patients will be received entecavir (10 mg/d) before liver resection.
DRUG	Tenofovir	Patients will be received tenofovir before liver resection.

Timeline

• Start date: 2021-02-02
• Primary completion: 2023-12-25
• Completion: 2023-12-30
• First posted: 2016-01-08
• Last updated: 2024-01-23

Locations

1 site across 1 country: China