TACE as an Adjuvant Therapy After Radiofrequency Ablation (RFA) for Hepatocellular Carcinoma (TACE-RFA)
Recruitment status was: Recruiting
|Hepatocellular Carcinoma Liver Cancer||Procedure: radiofrequency ablation Procedure: TACE after RFA||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Transcatheter Arterial Chemoembolization as an Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma|
- Overall survivals [ Time Frame: 3, and 5-years ]
- Recurrence rates [ Time Frame: 3, and 5-years ]
|Study Start Date:||November 2007|
|Estimated Study Completion Date:||June 2010|
|Estimated Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
TACE after RFA within one month as an adjuvant therapy
Procedure: TACE after RFA
TACE after RFA within one month
Other Name: TACE-RFA
Active Comparator: 2
Procedure: radiofrequency ablation
Other Name: RFA
Local ablation is a safe and effective therapy for patients who cannot undergo resection, or as a bridge to transplantation. Of the various percutaneous local ablative therapies, radiofrequency ablation (RFA) has attracted the greatest interest because of its effectiveness and safety for small HCC ≤ 5.0 cm, with a 3-year survival rate of 62% to 68%, a low treatment morbidity of 0% to 12%, and a low treatment mortality of 0% to 1%. Prospective randomized trials have shown RFA to be better than percutaneous ethanol injection (PEI) in producing a higher rate of complete tumor necrosis with fewer numbers of treatment sessions and better survival.
Unfortunately, the complete tumor necrosis rate for tumors larger than 5 cm is less favorable, and the local recurrence rate can be as high as 20% even in small HCC less than 3.5 cm. The high local recurrence rate may be due to residual cancer cells not killed by RFA or adjacent microscopic satellite tumor nodules.
Transcatheter Arterial Chemoembolization (TACE) has proven to be an effective and palliative therapy for unresectable HCC. And some prospective randomized controlled trials have shown that adjuvant TACE after curative resection for HCC can improve the overall survivals and decrease the recurrence rates. But there have not been any studies about TACE as an adjuvant therapy after RFA for HCC.
Thus, the purpose of this study is to prospectively evaluate whether TACE as an adjuvant therapy after RFA for HCC will improve the outcomes of RFA.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00556803
|Contact: Min-Shan Chen, M.D, Ph.D||86-20-87343117||Chminsh@mail.sysu.edu.cn|
|Department of Hepatobiliary Surgery, Cancer Center, Sun Yat-sen University||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Min-Shan Chen, M.D., Ph.D. 86-20-87343117 Chminsh@mail.sysu.edu.cn|
|Principal Investigator:||Min-Shan Chen, M.D., Ph.D.||Department of Hepatobiliary Surgery, Cancer Center, Sun Yat-sen University|