Adjuvant Entecavir or Tenofovir for Postoperative HBV-HCC

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02650271
• Other study ID #: AEVT-HCC
• Status: Completed
• Phase: Phase 3
• Start date: February 2, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: January 2024
• Source: Guangxi Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 30, 2023
• Est. primary completion date: December 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Entecavir
Patients will be received entecavir (10 mg/d) before liver resection.
• Tenofovir
Patients will be received tenofovir before liver resection.

Locations

Country	Name	City	State
China	Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University	Nanning	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Guangxi Medical University

Country where clinical trial is conducted

China, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Perioperative reactivation of hepatitis B virus replication		1-month
Primary	overall survival		1-year
Secondary	Recurrence rate		1-year