Trial Information

Radiofrequency Ablation Combined With Transcatheter Arterial Chemoembolization Versus Radiofrequency Ablation Alone for Recurrent Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is the fifth most common cancer in the world. Partial
hepatectomy and liver transplantation are considered to be standard curative therapies for
HCC. When surgery is not possible, percutaneous ablation is usually considered to be
alternative treatments for HCC . Recurrence is the most frequent serious adverse event
observed during the follow-up of HCC patients treated for cure. Repeat hepatectomy is an
effective treatment for HCC recurrence, with a 5-year survival rate of 19.4 to 56%.
Unfortunately, repeat hepatectomy can be performed only in a small proportion of patients
with HCC recurrence (10.4 to 31%), either because of the poor functional liver reserve or
because of widespread recurrence.(15, 17, 18) Radiofrequency ablation (RFA) has been
considered to be one of the most effective percutaneous ablations for early-stage HCC in
patients with or without surgical prospects . Studies using RFA to treat HCC recurrence
after hepatectomy have reported a 3-year survival rate of 62% to 68%, which is comparable to
those achieved by surgery. RFA is particularly suitable to treat HCC recurrence after
hepatectomy because these tumors are usually detected when they are small, and because RFA
causes the least deterioration of liver function in the patients. RFA is also effective for
managing HCC recurrence after initial treatment of RFA. Clinical data have shown that, after
repeated RFA, the estimated 3-and 5-year overall, and disease-free survival rates for
patients with HCC recurrence were 67.0% and 40.1% and 68.0 and 38.0%,
respectively.Therefore, we considered RFA to be an effective treatment for HCC recurrence
after curative treatment.

The combination of transcatheter arterial chemoembolization (TACE) with RFA has also
reported to be an effective treatment for HCC. Studies have shown TACE combined RFA to have
better efficacy than RFA for medium-sized HCC (3-5 cm) and multiple-tumor HCC, but not for
small HCC (≤3 cm). However, to our knowledge, there have not been any prospective studies
to assess whether TACE combined sequentially with RFA is more effective than RFA alone for
the treatment of HCC recurrence after curative treatment. We hypothesized that the
combination of TACE and RFA might result in better patient survival than RFA alone. Thus,
the purpose of this study was to prospectively compare the effects of sequential TACE-RFA
with RFA alone for the treatment of recurrent HCC. Recurrent HCC in this study was defined
as new tumors in the remnant liver, distant from the resection or ablation site after
curative treatment of RFA or hepatectomy.