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:
Participant gender:
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.