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CompletedNCT02650271Updated Jan 23, 2024

Adjuvant Entecavir or Tenofovir for Postoperative HBV-HCC

A Phase 3 interventional study of Entecavir and Tenofovir in Hepatocellular Carcinoma, sponsored by Guangxi Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-23.

Sponsored by Guangxi Medical University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Hepatocellular Carcinoma

Keywords

  • adjuvant
  • entecavir
  • hepatocellular carcinoma
  • hepatic resection
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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 240 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Guangxi Medical University is the lead sponsor of 68 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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

Exclusion Criteria:

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

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
240 participants (actual)

Study arms

  • Experimental
    Entecavir

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

    Drug: Entecavir

  • Active comparator
    Tenofovir

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

    Drug: Tenofovir

Interventions

  • DrugEntecavir

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

    Also known as: ETV

  • DrugTenofovir

    Patients will be received tenofovir before liver resection.

06

What researchers measure

Primary outcomes

  1. overall survival

    Time frame: 1-year

Secondary outcomes

  1. Recurrence rate

    Time frame: 1-year

Other outcomes

  1. Perioperative reactivation of hepatitis B virus replication

    Time frame: 1-month

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Study locations

1 site
  • Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University
    Nanning, Guangxi 530021, China
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References and documents

Publications

  • 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. PubMed 24379991 ↗
  • 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. PubMed 30959156 ↗
  • 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. PubMed 31843789 ↗
  • 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. PubMed 35080052 ↗
  • 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. PubMed 38183137 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02650271
Lead sponsor
Guangxi Medical University
Responsible party
Jian-Hong Zhong (Director, Guangxi Medical University) — Principal investigator
First posted
Jan 8, 2016
Start date
Feb 2, 2021
Primary completion
Dec 25, 2023
Completion
Dec 30, 2023
Last update
Jan 23, 2024

Study contacts

Le-Qun Li, MD
study chair · Guangxi Medical University Cancer Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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