Combine TACE and RFA Versus RFA Monotherapy in Unilobar HCC of 3.1 to 7 cm Patient

• Status: Unknown status
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Abstract of Research Proposal Radiofrequency ablation (RFA) has been proved to be a curative treatment with minimal invasiveness and high efficacy for small hepatocellular carcinoma (HCC) that is generally defined as maximal diameter no larger than 3cm. RFA can achieve a rate of complete necrosis as 80-100% in small HCC. However, the rate will drop to 71% in HCC of 3.1-5cm and 25% for HCC larger than 5cm。This is due to the relative hypervascularity for the bigger tumor and it will induce heat sink that leading to less effect of ablation. Therefore, transcatheter chemoembolization (TACE) before RFA may reduce the vascularity and enhance the effect of subsequent RFA. Moreover, pre-RF TACE will reduce the tumor size and the subsequent RFA will be more effective than RFA alone. In retrospective studies, Kitamoto M et al showed that tumor necrosis diameter was larger in TACE and RFA combination therapies compared to RFA mono-therapy; Yamakado K et al showed that TACE and RFA combination therapies in HCC (maximal diameter up to 12 cm) achieved 100% complete necrosis, 0% local recurrence rate and 93% of 2-year survival rate. Nevertheless, only one randomized trial in intermediate size HCC (3-5cm in diameter) showed that TACE and RFA combination therapies achieved a significant higher rate of complete necrosis, technique success, fewer treatment sessions to achieve complete necrosis and lower local recurrence but non-significant difference in 3-year survival rate. Therefore, based on the limited studies, combine TACE and RFA may achieve better effects than RFA mono-therapy in HCC larger than 3cm. However, repeat TACE may induce some complications such as HBV reactivation, hepatitis or even liver decompensation. Moreover, novel RFA using simultaneous multiple RFA probes with switching RF controller may achieve a better effects and shorter ablation time than sequential RFA with single electrode. Thus, is it still necessary using TACE and RFA combination therapies for HCC >3cm when application of novel switching RF controller? The aim of the current study is to conduct a RCT comparing combine TACE and RFA compared to RFA mono-therapy by using simultaneous multiple electrodes and switching RF controller in uni-lobar HCC of 3.1-7cm. The rate of complete necrosis, technique success, sessions to achieve CN, local tumor progression, survival rate and major complications will be analyzed. Investigators cannot expect which one is better, safer before the achievement of the study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shi-Ming Lin
• Treatments: Doxorubicin; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• Age >18 years;

• Unresectable HCC or patients with resectable HCC but not appropriate for resection;.

• Tumor stage: single tumor with 3.1-7cm in diameter, or multiple (maximum 3) tumors with at least one over 3cm but only one of the multiple tumors larger than 5cm for concerning too prolonged time of RFA. All the target tumors are located in single lobe.

• The lesion should be detected on ultrasonography;

• The divergence of the hepatic artery was suitable for TACE;

• Absence of portal and venous thrombosis, extrahepatic metastases, or uncontrollable ascites;

• Patients in Child-Pugh grade A or B;

• Eastern Cooperative Oncology Group performance status score of 2 or less;

• Patient has signed consent form regarding participation in the study.

Exclusion Criteria:

• Patients had previously received any treatment for HCC;

• Patients with known renal or cardiovascular disease before TACE;

• Child-Pugh grade C cirrhosis, prior decompensation and history of encephalopathy before TACE

• Pregnancy or plan to pregnant in the subsequent study period (1 to 2 years)