Clinical trial · Interventional
Adjuvant Entecavir or Tenofovir for Postoperative HBV-HCC
Adjuvant Entecavir or Tenofovir for Hepatitis B Virus Related Hepatocellular Carcinoma After Curative Hepatic Resection
NCT02650271CI-TRIAL-00073195completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Entecavir | Drug | — | UNRESOLVED |
| Tenofovir | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Entecavir
- description
- Patients will be received entecavir (10 mg/d) after 3 days of liver resection.
- interventionNames
- Drug: Entecavir
- type
- ACTIVE_COMPARATOR
- label
- Tenofovir
- description
- Patients will be received tenofovir (1#/d) after 3 days of liver resection.
- interventionNames
- Drug: Tenofovir
Primary outcomes (1)
- measure
- overall survival
- timeFrame
- 1-year
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (5)
- BACKGROUNDKe 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. PMID 24379991
- BACKGROUNDKim 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. PMID 30959156
- BACKGROUNDTeng 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. PMID 31843789
- BACKGROUNDYuan 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. PMID 35080052
- BACKGROUNDPan 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. PMID 38183137