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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02650271

Enrollment

240

Registered

2016-01-08

Start date

2021-02-02

Completion date

2023-12-30

Last updated

2024-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

adjuvant, entecavir, hepatocellular carcinoma, hepatic resection

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.

Interventions

DRUGEntecavir

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

DRUGTenofovir

Patients will be received tenofovir before liver resection.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
overall survival	1-year

Secondary

Measure	Time frame
Recurrence rate	1-year

Other

Measure	Time frame
Perioperative reactivation of hepatitis B virus replication	1-month

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026