| November 7, 2007 |
| March 31, 2009 |
| November 2007 |
| December 2009 (final data collection date for primary outcome measure) |
| Overall survivals [ Time Frame: 3, 5-years ] [ Designated as safety issue: Yes ] |
| overall survivals [ Time Frame: 3, 5-years ] |
| Complete list of historical versions of study NCT00555334 on ClinicalTrials.gov Archive Site |
| Recurrence rates [ Time Frame: 3, 5-years ] [ Designated as safety issue: Yes ] |
| recurrence rates [ Time Frame: 3, 5-years ] |
| |
| Nucleoid as an Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma |
| Nucleoid as an Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma |
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). |
| |
| Phase IV |
| Interventional |
| Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study |
- Hepatocellular Carcinoma
- Liver Cancer
|
- Procedure: RFA
- Drug: lamivudine or entecavir
|
- Experimental: nucleoid antiviral therapy after RFA
- Active Comparator: RFA only
|
- 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. Review.
- 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.
- 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.
|
| |
| Recruiting |
| 200 |
| December 2010 |
| December 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Inclusion Criteria:
- Age 18 - 75 years, who refused surgery;
- A solitary HCC ≤ 7.0cm in diameter, or multiple HCC ≤ 3 lesions, each ≤ 3.0cm in diameter
- Lesions being visible on ultrasound (US) and with an acceptable/safe path between the lesion and the skin as shown on US,
- No extrahepatic metastasis
- No imaging evidence of invasion into the major portal/hepatic vein branches
- No history of encephalopathy, ascites refractory to diuretics or variceal bleeding
- A platelet count of > 40,000/mm3
- No previous treatment of HCC except liver resection.
Exclusion Criteria:
|
| Both |
| 18 Years to 75 Years |
| No |
|
|
| China |
| |
| NCT00555334 |
| CancerCcanter, Sun Yat-sen University, Cancer Canter, Sun Yat-sen University |
| RFA-002 |
| Sun Yat-sen University |
|
| Principal Investigator: |
min-shan chen, doctor |
Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University |
|
|
| Sun Yat-sen University |
| March 2009 |