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Adjuvant Entecavir or Tenofovir for Postoperative HBV-HCC

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ClinicalTrials.gov Identifier: NCT02650271
Recruitment Status : Recruiting
First Posted : January 8, 2016
Last Update Posted : January 18, 2022
Sponsor:
Information provided by (Responsible Party):
Jian-Hong Zhong, Guangxi Medical University

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
Hepatocellular Carcinoma Drug: Entecavir Drug: Tenofovir 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 2, 2021
Estimated Primary Completion Date : December 25, 2022
Estimated Study Completion Date : December 30, 2022


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 Name: 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.




Primary Outcome Measures :
  1. overall survival [ Time Frame: 1-year ]

Secondary Outcome Measures :
  1. Recurrence rate [ Time Frame: 1-year ]

Other Outcome Measures:
  1. Perioperative reactivation of hepatitis B virus replication [ Time Frame: 1-month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02650271


Contacts
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Contact: Jian-Hong Zhong, MD 86-771-5330855 zhongjianhong66@163.com

Locations
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China, Guangxi
Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University Recruiting
Nanning, Guangxi, China, 530021
Contact: Jian-Hong Zhong, MD       zhongjianhong66@163.com   
Sponsors and Collaborators
Guangxi Medical University
Publications of Results:
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Responsible Party: Jian-Hong Zhong, Director, Guangxi Medical University
ClinicalTrials.gov Identifier: NCT02650271    
Other Study ID Numbers: AEVT-HCC
First Posted: January 8, 2016    Key Record Dates
Last Update Posted: January 18, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jian-Hong Zhong, Guangxi Medical University:
adjuvant
entecavir
hepatocellular carcinoma
hepatic resection
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Tenofovir
Entecavir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents