- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02650271
Adjuvant Entecavir or Tenofovir for Postoperative HBV-HCC
Adjuvant Entecavir or Tenofovir for Hepatitis B Virus Related Hepatocellular Carcinoma After Curative Hepatic Resection
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Jian-Hong Zhong, MD
- Phone Number: 86-771-5330855
- Email: zhongjianhong66@163.com
Study Contact Backup
- Name: Liang Ma, MD
- Phone Number: 86-771-5301253
- Email: malianggxyd@163.com
Study Locations
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Guangxi
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Nanning, Guangxi, China, 530021
- Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Entecavir
Patients will be received entecavir (10 mg/d) after 3 days of liver resection.
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Patients will be received entecavir (10 mg/d) before liver resection.
Other Names:
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Active Comparator: Tenofovir
Patients will be received tenofovir (1#/d) after 3 days of liver resection.
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Patients will be received tenofovir before liver resection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: 1-year
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1-year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Recurrence rate
Time Frame: 1-year
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1-year
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Perioperative reactivation of hepatitis B virus replication
Time Frame: 1-month
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1-month
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Le-Qun Li, MD, Guangxi Medical University Cancer Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Tenofovir
- Entecavir
Other Study ID Numbers
- AEVT-HCC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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