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The current study is a prospective, randomized, open, multi-center investigation. The aim of current study is to investigate whether the Recurrence-free Survival Rate (RFS）of the hepatitis B related -hepatocellular carcinoma subjects who have been treated by resection can be improved by peginterferon alfa-2a
The subjects who have been treated by resection due to hepatocellular carcinoma (HCC) will be randomized into 2 groups: the subjects in group A will be treated by Nucleotide analogues (NAs)( ETV, 0.5mg，qd；tenofovir disoproxil fumarate(TDF)，300mg，qd；ADV，10mg，qd）for 96 weeks; the subjects in group B will be treated by peginterferon alfa-2a （135μg/week）combination with NAs (ETV\TDF\ADV)for 96 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | The subjects will be treated by NAs (ETV, 0.5mg，qd；TDF，300mg，qd；ADV，10mg，qd）for 96 weeks |
|
| Group B | Experimental | The subjects will be treated by peginterferon alfa-2a （135μg/week）combination with NAs(ETV\TDF\ADV) for 96 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ETV；TDF；ADV | Drug | NAs |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-free Survival Rate (RFS） | Number of subjects without Recurrence in the total subjects | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-free Survival Rate (RFS） | Number of subjects without Recurrence in the total subjects | 1 year |
| Overall Survival Rate (OS） | Number of subjects with survival in the total subjects |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lunxiu Qin | Contact | 52887172 | qinlx@fudan.edu.cn | |
| Huliang Jia | Contact | jbl-1@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lunxiu Qin | Huashan Hospital | Principal Investigator |
| Jimimg Zhang | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital | Recruiting | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16557381 | Background | Sun HC, Tang ZY, Wang L, Qin LX, Ma ZC, Ye QH, Zhang BH, Qian YB, Wu ZQ, Fan J, Zhou XD, Zhou J, Qiu SJ, Shen YF. Postoperative interferon alpha treatment postponed recurrence and improved overall survival in patients after curative resection of HBV-related hepatocellular carcinoma: a randomized clinical trial. J Cancer Res Clin Oncol. 2006 Jul;132(7):458-65. doi: 10.1007/s00432-006-0091-y. Epub 2006 Mar 24. | |
| 24619495 |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
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| Peginterferon Alfa-2a | Drug | peginterferon |
|
|
| 2 years |
| Overall Survival Rate (OS） | Number of subjects with survival in the total subjects | 1 year |
| Background |
| Sohn W, Paik YH, Kim JM, Kwon CH, Joh JW, Cho JY, Gwak GY, Choi MS, Lee JH, Koh KC, Paik SW, Yoo BC. HBV DNA and HBsAg levels as risk predictors of early and late recurrence after curative resection of HBV-related hepatocellular carcinoma. Ann Surg Oncol. 2014 Jul;21(7):2429-35. doi: 10.1245/s10434-014-3621-x. Epub 2014 Mar 12. |
| 23046671 | Background | Micco L, Peppa D, Loggi E, Schurich A, Jefferson L, Cursaro C, Panno AM, Bernardi M, Brander C, Bihl F, Andreone P, Maini MK. Differential boosting of innate and adaptive antiviral responses during pegylated-interferon-alpha therapy of chronic hepatitis B. J Hepatol. 2013 Feb;58(2):225-33. doi: 10.1016/j.jhep.2012.09.029. Epub 2012 Oct 6. |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |