TACE as an Adjuvant Therapy After Radiofrequency Ablation (RFA) for Hepatocellular Carcinoma — TACE-RFA  

Hepatocellular Carcinoma Clinical Trial

Official title: Transcatheter Arterial Chemoembolization as an Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma

Status Recruiting

Clinical Trial Summary

The purpose of this study is to prospectively evaluate whether transcatheter arterial chemoembolization (TACE) will improve the outcome of radiofrequency ablation for hepatocellular carcinoma (HCC) or not.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Cancer
• Liver Neoplasms

• NCT number: NCT00556803
• Study type: Interventional
• Source: Sun Yat-sen University
• Contact: Min-Shan Chen, M.D, Ph.D
• Phone: 86-20-87343117
• Email: Chminsh@mail.sysu.edu.cn
• Status: Recruiting
• Phase: Phase 4
• Start date: November 2007
• Completion date: June 2010