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Adjuvant Entecavir or Tenofovir for Postoperative HBV-HCC

Primary Purpose

Hepatocellular Carcinoma

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Entecavir

Tenofovir

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring adjuvant, entecavir, hepatocellular carcinoma, hepatic resection

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Entecavir

Tenofovir

Arm Description

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

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

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

Recurrence rate

Full Information

NCT ID

NCT02650271

First Posted

January 5, 2016

Last Updated

January 27, 2023

Sponsor

Guangxi Medical University

1. Study Identification

Unique Protocol Identification Number

NCT02650271

Brief Title

Adjuvant Entecavir or Tenofovir for Postoperative HBV-HCC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 2, 2021 (Actual)

Primary Completion Date

December 25, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guangxi Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

Keywords

adjuvant, entecavir, hepatocellular carcinoma, hepatic resection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Entecavir

Arm Type

Experimental

Arm Description

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

Arm Title

Tenofovir

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Entecavir

Other Intervention Name(s)

ETV

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Tenofovir

Intervention Description

Patients will be received tenofovir before liver resection.

Primary Outcome Measure Information:

Title

overall survival

Time Frame

1-year

Secondary Outcome Measure Information:

Title

Recurrence rate

Time Frame

1-year

Other Pre-specified Outcome Measures:

Title

Perioperative reactivation of hepatitis B virus replication

Time Frame

1-month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jian-Hong Zhong, MD

Phone

86-771-5330855

zhongjianhong66@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Liang Ma, MD

Phone

86-771-5301253

malianggxyd@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Le-Qun Li, MD

Organizational Affiliation

Guangxi Medical University Cancer Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University

City

Nanning

State/Province

Guangxi

ZIP/Postal Code

530021

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jian-Hong Zhong, MD

zhongjianhong66@163.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

24379991

Citation

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.

Results Reference

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PubMed Identifier

30959156

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.

Results Reference

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PubMed Identifier

31843789

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.

Results Reference

background

PubMed Identifier

35080052

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.

Results Reference

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Adjuvant Entecavir or Tenofovir for Postoperative HBV-HCC

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