cy, including improvement in tumor imaging parameters, decrease in serum α-fetoprotein (AFP) levels, symptom relief (i.e. Karnofsky Performance Status and numerical rating scales) and response rates, and long term efficacy, including an increase in survival rates and improvement of quality of life (QOL), was monitored. Results: Tumor imaging parameters, serum AFP levels and symptom scores improved significantly in the HIFU group compared with the control group (all P < 0.05). In the HIFU group, a complete and a partial response were achieved in 28.5% (n = 43) and 60.3% (n = 91) of cases, respectively, while the rates were 0% and 16.7% (n = 5), respectively, in the control group. The overall response rate (88.8%) was significantly greater in the HIFU group (16.7%) than in the control group (P < 0.01). In addition, the 1- and 2-year survival rates were 50.0% and 30.9%, respectively, in the HIFU group, which were significantly greater than those (3.4% and 0%, respectively) in the control group (both P < 0.01). The QOLscore was 83.1 ± 8.0 at 3 months after HIFU, which was significantly greater than the pre-HIFU score (67.7 ± 5.9) and the score at 3 months after treatment (69.0 ± 8.5) in the control group (both P < 0.05). No severe complications occurred during and after HIFU. Conclusion: HIFU is an effective and safe ablation therapy with satisfactory short and long term efficacy for patients with advanced HCC.