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The purpose of the investigators' study is to prospectively evaluate whether nucleoid antiviral therapy will improve the outcome of radiofrequency ablation for hepatocellular carcinoma (HCC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | nucleoid antiviral therapy after RFA |
|
| 2 | Active Comparator | RFA only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RFA | Procedure | radiofrequency ablation |
| |
| lamivudine or entecavir |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survivals | 3, 5-years |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rates | 3, 5-years |
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Inclusion Criteria:
Exclusion Criteria:
Patient compliance is poor
The blood supply of tumor lesions is absolutely poor or arterial-venous shunt that TACE can not be performed
Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to entry is permitted.
History of cardiac disease:
Active clinically serious infections (> grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)
Known history of human immunodeficiency virus (HIV) infection
Known Central Nervous System tumors including metastatic brain disease
Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
Distantly extrahepatic metastasis
History of organ allograft
Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
Known or suspected allergy to the investigational agent or any agent given in association with this trial
Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.
Excluded therapies and medications, previous and concomitant:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min-Shan Chen, Docter | Contact | 86-20-87343117 | 86-20-87343117 | Chminsh@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| min-shan chen, doctor | Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16250051 | Background | Bruix J, Sherman M; Practice Guidelines Committee, American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma. Hepatology. 2005 Nov;42(5):1208-36. doi: 10.1002/hep.20933. No abstract available. | |
| 11923602 | Background | Poon RT, Fan ST, Tsang FH, Wong J. Locoregional therapies for hepatocellular carcinoma: a critical review from the surgeon's perspective. Ann Surg. 2002 Apr;235(4):466-86. doi: 10.1097/00000658-200204000-00004. |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D019259 | Lamivudine |
| C413685 | entecavir |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Drug |
lamivudine (100mg qd) or entecavir (0.5mg qd) after RFA |
|
|
| 16495695 | Background | Chen MS, Li JQ, Zheng Y, Guo RP, Liang HH, Zhang YQ, Lin XJ, Lau WY. A prospective randomized trial comparing percutaneous local ablative therapy and partial hepatectomy for small hepatocellular carcinoma. Ann Surg. 2006 Mar;243(3):321-8. doi: 10.1097/01.sla.0000201480.65519.b8. |
| 11419162 | Background | Buscarini L, Buscarini E, Di Stasi M, Vallisa D, Quaretti P, Rocca A. Percutaneous radiofrequency ablation of small hepatocellular carcinoma: long-term results. Eur Radiol. 2001;11(6):914-21. doi: 10.1007/s003300000659. |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |