Randomized Clinical Trial Of Transcatheter Arterial Chemoembolization Plus Radiofrequency Ablation Versus Transcatheter Arterial Chemoembolization For Hepatocellular Carcinoma With Intermediate Stage (Bclc Stage B) Hepatocellular Carcinoma Beyond Milan Criteria.

4077 Background: To determine treatment efficacy and safety of transarterial chemoembolization (TACE) combined with radiofrequency ablation (RFA) (hereafter, TACE+RFA) in patients with intermediate stage (BCLC stage B) hepatocellular carcinoma (HCC) beyond Milan criteria. Methods: In this randomized clinical trial, 110 patients with intermediate stage HCC beyond Milan criteria (single tumor with diameter 5-7cm, median; 3-5 multiple nodules with diameter less than 5cm) were included and randomly assigned to TACE+RFA group (n=55) and TACE group (n=55) at liver cancer institute, Zhongshan hospital. The primary endpoint was overall survival (OS). The secondary end point was progression-free survival (PFS) , time to progress (TTP) and best objective response (BOR). Results: The median OS in TACE+RFA and TACE group were 29 and 18 months, respectively. The median TTP and BOR were 15.7 months and 69.1 % in TACE+RFA group and 12.4 months and 40.0 % in TACE group (P=0.004). The 1-, 3-, and 4-year overall survivals for TACE+RFA group and TACE group were 97.2%, 67.9% and 59.4% versus 84.0%, 46.7% and 37.3% , respectively (P = 0.008). The corresponding PFS were 47.3%, 27.2% and 21.7% versus 35.6%,15.3% and 11.4% , respectively (P = 0.04).The incidences of major complications in TACE+RFA group were comparable to those in TACE group (P=0.14). Conclusions: TACE+RFA was superior to TACE in improving tumor response and overall survival for patients with intermediate stage (BCLC stage B) hepatocellular carcinoma beyond Milan criteria. Clinical trial information: NCT03636620.