Two-center phase 3 trial of transarterial chemoembolization plus thermal ablation in unresectable hepatocellular carcinoma

Transarterial chemoembolization (TACE) is the standard of care for liver-confined hepatocellular carcinoma (HCC) that is not amenable to curative treatment; however, TACE has demonstrated unsatisfactory survival benefits. The phase 3 TORCH trial, at two centers in China, evaluated whether combining TACE with subsequent thermal ablation improves clinical outcomes compared with TACE alone in patients with liver-confined unresectable HCC. The trial enrolled patients with BCLC stage B HCC, who were randomized 1:1 to TACE-ablation (n=121) or TACE alone (n=120). The primary endpoint was progression-free survival (PFS). The median PFS was 17.7 months in the TACE-ablation group versus 7.3 months in the TACE alone group (HR 0.47; p<0.001) and the median overall survival (OS) was 88.6 months versus 35.1 months (HR 0.50; pxtagstartz0.001). Clinically meaningful improvements in both PFS and OS were observed in patients with low to moderate tumor burden scores (≤6 and 6-12 points). Grade 3 and 4 treatment-related adverse events occurred in 23.2% of patients in the TACE-ablation group and 18.3% in the TACE alone group. The authors conclude that addition of thermal ablation to TACE was associated with significantly improved survival outcomes in patients with liver-confined unresectable HCC.