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Most hepatocellular carcinomas are associated with hepatitis B virus, it is hypothesized that anti-viral treatment may be helpful in treating HBV-related hepatocellular carcinoma.
As we know, recurrence and metastasis could happen in hepatocellular carcinoma even after radical resection.One reason is that virus hepatitis B could be one factor contributing to the carcinogenesis of hepatocellular carcinoma.To investigated whether anti-viral therapy could improve the efficacy of radical resection of hepatitis B virus (HBV)-related hepatocellular carcinoma(HCC),we planed to conduct this clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| antiviral group | Experimental | Drug: antiviral treatment(lamivudine or entecavir) after the Procedure/Surgery (radical resection of HBV-related HCC) |
|
| control group | Active Comparator | Procedure/Surgery (radical resection of HBV-related HCC) without Drug of antiviral treatment - close observation without antiviral treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| antiviral treatment (lamivudine or entecavir) | Drug | antiviral treatment (lamivudine 100mg per day or entecavir 0.5mg per day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survivals | 2,3,5years |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate | 2,3,5years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiang-Ming LAO, Ph.D | Contact | 8620-87343115 | laoxming@mail.sysu.edu.cn | |
| Xiao-Jun LIN, Ph.D | Contact | 8620-87343017 | sumslxm@sohu.com |
| Name | Affiliation | Role |
|---|---|---|
| Jin-Qing LI, Ph.D | Sun Yat-sen University | Principal Investigator |
| Min-Shan CHEN, Ph.D | Sun Yat-sen University | Study Director |
| Xiao-Jun LIN, Ph.D |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiang-Ming Lao | Recruiting | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16440357 | Background | Jang JW, Choi JY, Bae SH, Yoon SK, Chang UI, Kim CW, Cho SH, Han JY, Lee YS. A randomized controlled study of preemptive lamivudine in patients receiving transarterial chemo-lipiodolization. Hepatology. 2006 Feb;43(2):233-40. doi: 10.1002/hep.21024. | |
| 17724708 | Background | Jang JW, Choi JY, Bae SH, Yoon SK, Woo HY, Chang UI, Kim CW, Nam SW, Cho SH, Yang JM, Lee CD. The impact of hepatitis B viral load on recurrence after complete necrosis in patients with hepatocellular carcinoma who receive transarterial chemolipiodolization: implications for viral suppression to reduce the risk of cancer recurrence. Cancer. 2007 Oct 15;110(8):1760-7. doi: 10.1002/cncr.22984. |
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| radical resection of HBV-related HCC | Procedure | Procedure/Surgery - radical resection of HBV-related HCC |
|
| Sun Yat-sen University |
| Study Director |
| Xiang-Ming LAO, Ph.D | Sun Yat-sen University | Study Chair |
| 15336446 | Background | Jang JW, Choi JY, Bae SH, Kim CW, Yoon SK, Cho SH, Yang JM, Ahn BM, Lee CD, Lee YS, Chung KW, Sun HS. Transarterial chemo-lipiodolization can reactivate hepatitis B virus replication in patients with hepatocellular carcinoma. J Hepatol. 2004 Sep;41(3):427-35. doi: 10.1016/j.jhep.2004.05.014. |
| 17881079 | Background | Poon RT. Significance of viral status on prognosis after resection of hepatitis B virus related hepatocellular carcinoma. J Hepatol. 2007 Nov;47(5):630-1. doi: 10.1016/j.jhep.2007.08.007. Epub 2007 Sep 5. No abstract available. |
| 17854945 | Background | Sun HC, Zhang W, Qin LX, Zhang BH, Ye QH, Wang L, Ren N, Zhuang PY, Zhu XD, Fan J, Tang ZY. Positive serum hepatitis B e antigen is associated with higher risk of early recurrence and poorer survival in patients after curative resection of hepatitis B-related hepatocellular carcinoma. J Hepatol. 2007 Nov;47(5):684-90. doi: 10.1016/j.jhep.2007.06.019. Epub 2007 Aug 13. |
| 12098045 | Background | Kubo S, Hirohashi K, Yamazaki O, Matsuyama M, Tanaka H, Horii K, Shuto T, Yamamoto T, Kawai S, Wakasa K, Nishiguchi S, Kinoshita H. Effect of the presence of hepatitis B e antigen on prognosis after liver resection for hepatocellular carcinoma in patients with chronic hepatitis B. World J Surg. 2002 May;26(5):555-60. doi: 10.1007/s00268-001-0267-1. Epub 2002 Feb 19. |
| 11141236 | Background | Kubo S, Nishiguchi S, Hamba H, Hirohashi K, Tanaka H, Shuto T, Kinoshita H, Kuroki T. Reactivation of viral replication after liver resection in patients infected with hepatitis B virus. Ann Surg. 2001 Jan;233(1):139-45. doi: 10.1097/00000658-200101000-00020. |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D006509 | Hepatitis B |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019259 | Lamivudine |
| C413685 | entecavir |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
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