NCT02650271

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P25-P50 for phase_3 hepatocellular-carcinoma

Timeline
Completed

Started Feb 2021

Shorter than P25 for phase_3 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 8, 2016

Completed
5.1 years until next milestone

Study Start

First participant enrolled

February 2, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

2.9 years

First QC Date

January 5, 2016

Last Update Submit

January 21, 2024

Conditions

Hepatocellular Carcinoma

Keywords

adjuvantentecavirhepatocellular carcinomahepatic resection

Outcome Measures

Primary Outcomes (1)

  • overall survival

    1-year

Secondary Outcomes (1)

  • Recurrence rate

    1-year

Other Outcomes (1)

  • Perioperative reactivation of hepatitis B virus replication

    1-month

Study Arms (2)

Entecavir

EXPERIMENTAL

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

Drug: Entecavir

Tenofovir

ACTIVE COMPARATOR

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

Drug: Tenofovir

Interventions

EntecavirDRUG

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

Also known as: ETV
Entecavir
TenofovirDRUG

Patients will be received tenofovir before liver resection.

Tenofovir

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Anti-HCV(+)
  • Diagnosis of HCC was not confirmed by postoperative histopathology of surgical samples after surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University

Nanning, Guangxi, 530021, China

Location

Related Publications (5)

  • Ke Y, Ma L, You XM, Huang SX, Liang YR, Xiang BD, Li LQ, Zhong JH. Antiviral therapy for hepatitis B virus-related hepatocellular carcinoma after radical hepatectomy. Cancer Biol Med. 2013 Sep;10(3):158-64. doi: 10.7497/j.issn.2095-3941.2013.03.006.

    PMID: 24379991BACKGROUND

  • Kim SU, Seo YS, Lee HA, Kim MN, Lee YR, Lee HW, Park JY, Kim DY, Ahn SH, Han KH, Hwang SG, Rim KS, Um SH, Tak WY, Kweon YO, Kim BK, Park SY. A multicenter study of entecavir vs. tenofovir on prognosis of treatment-naive chronic hepatitis B in South Korea. J Hepatol. 2019 Sep;71(3):456-464. doi: 10.1016/j.jhep.2019.03.028. Epub 2019 Apr 6.

    PMID: 30959156BACKGROUND

  • Teng YX, Li MJ, Xiang BD, Zhong JH. Tenofovir may be superior to entecavir for preventing hepatocellular carcinoma and mortality in individuals chronically infected with HBV: a meta-analysis. Gut. 2020 Oct;69(10):1900-1902. doi: 10.1136/gutjnl-2019-320326. Epub 2019 Dec 16. No abstract available.

    PMID: 31843789BACKGROUND

  • Yuan BH, Li RH, Huo RR, Li MJ, Papatheodoridis G, Zhong JH. Lower risk of hepatocellular carcinoma with tenofovir than entecavir treatment in subsets of chronic hepatitis B patients: an updated meta-analysis. J Gastroenterol Hepatol. 2022 May;37(5):782-794. doi: 10.1111/jgh.15783. Epub 2022 Feb 7.

    PMID: 35080052BACKGROUND

  • Pan LX, Wang YY, Li ZH, Luo JX, Wu KJ, Liu ZX, Wu PS, Chen K, Ma L, Fan XH, Zhong JH. Entecavir versus tenofovir for prevention of hepatitis B virus-associated hepatocellular carcinoma after curative resection: study protocol for a randomized, open-label trial. Trials. 2024 Jan 5;25(1):25. doi: 10.1186/s13063-023-07742-x.

    PMID: 38183137BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

entecavirTenofovir

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Le-Qun Li, MD

    Guangxi Medical University Cancer Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

January 5, 2016

First Posted

January 8, 2016

Study Start

February 2, 2021

Primary Completion

December 25, 2023

Study Completion

December 30, 2023

Last Updated

January 23, 2024

Record last verified: 2024-01

Locations

CN(1)