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. 2022 Feb;13(1):426–437. doi: 10.21037/jgo-21-274

Table 1. Lists a summary of the TKI’s that are FDA approved in advanced HCC.

Trial name Author No. of patients Study arm ECOG Child-Pugh score BCLC stage Primary endpoint
SHARP Llovet et al. (5) 602 Sorafenib vs. placebo (first-line setting) 0 to 2 A B OS: 10.7 vs. 7.9 months; hazard ratio (HR) =0.69; P<0.001; TTP: 4.1 vs. 4.9 months, P=0.77
REFLECT Kudo et al. (8) 954 Lenvantinib vs. sorafenib (first-line setting) 0 or 1 A B or C OS: lenvatinib 13.6 months (95% CI: 12.1–14.9) vs. sorafenib (12.3 months, 95% CI: 10.4–13.9) (HR =0.92, 95% CI: 0.79–1.06)
CELESTIAL Abou-Alfa et al. (9) 707 Cabozantinib vs. placebo (second-line setting) 0 or 1 A OS: cabozantinib 10.2 vs. 8.0 months with placebo (HR =0.76; 95% CI: 0.63–0.92; P=0.005)
RESORCE Bruix et al. (10) 567 Regorafenib vs. placebo (second-line setting) 0 or 1 A B or C OS: 10.6 months (95% CI: 9.1–12.1) for regorafenib vs. 7.8 months (6.3–8.8) for placebo, HR =0.63 (95% CI: 0.50–0.79; P<0.0001)

TKI, tyrosine kinase inhibitors; HCC, hepatocellular carcinoma; OS, overall survival; HR, hazard ratio.