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Adjuvant Entecavir or Tenofovir for Postoperative HBV-HCC

Sponsor
Guangxi Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT02650271
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
22.9
Anticipated Duration (Months)
5.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Adjuvant Entecavir or Tenofovir for Hepatitis B Virus Related Hepatocellular Carcinoma After Curative Hepatic Resection
Actual Study Start Date :
Feb 2, 2021
Anticipated Primary Completion Date :
Dec 25, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Entecavir

Patients will be received entecavir (10 mg/d) after 3 days of liver resection.

Drug: Entecavir
Patients will be received entecavir (10 mg/d) before liver resection.
Other Names:
  • ETV

    		•
    Active Comparator: Tenofovir

    Patients will be received tenofovir (1#/d) after 3 days of liver resection.

    Drug: Tenofovir
    Patients will be received tenofovir before liver resection.

    Outcome Measures

    Primary Outcome Measures

    1. overall survival [1-year]

    Secondary Outcome Measures

    1. Recurrence rate [1-year]

    Other Outcome Measures

    1. Perioperative reactivation of hepatitis B virus replication [1-month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University Nanning Guangxi China 530021

    Sponsors and Collaborators

    • Guangxi Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jian-Hong Zhong, Director, Guangxi Medical University
    ClinicalTrials.gov Identifier:
    NCT02650271
    Other Study ID Numbers:
    • AEVT-HCC
    First Posted:
    Jan 8, 2016
    Last Update Posted:
    Jan 18, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jian-Hong Zhong, Director, Guangxi Medical University
    adjuvant
    entecavir
    hepatocellular carcinoma
    hepatic resection
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular
    Tenofovir
    Entecavir

    Study Results

    No Results Posted as of Jan 18, 2022