TABLE 3.
Selected randomised controlled trials identifying locoregional therapies combined with systemic agents in HCC.
| Trial | BCLC stage | Region | Arms | Endpoints | Outcomes |
|---|---|---|---|---|---|
| Local ablation combined with systemic agents | |||||
| Zhou et al., 2023 | Intermediate/advanced (second line) | China | Local ablation plus toripalimab (n = 65) versus toripalimab alone (n = 65) | PFS | 7.1 versus 3.8 months, HR 0.57 (95% CI 0.40–0.82); p < 0.001 |
| TACE combined with systemic agents | |||||
| Kudo et al., 2011 (POST‐TACE trial) | Early/intermediate | Japan, South Korea | cTACE (responders) plus sorafenib (n = 229) versus cTACE plus placebo (n = 229) | TTP | 5.4 versus 3.7; HR 0.87 (95% CI 0.70–1.09); p = 0.252 |
| Kudo et al., 2014 (BRISK‐TA trial) | Early/intermediate/advanced | Global | cTACE or DEB‐TACE plus brivanib (n = 249) versus cTACE plus placebo (n = 253) | OS | 26.4 versus 26.1 months; HR 0.90 (95% CI 0.66–1.23); p = 0.53 |
| Lencioni et al., 2016 (SPACE trial) | Intermediate | Global | DEB‐TACE plus sorafenib (n = 154) versus DEB‐TACE plus placebo (n = 153) | TTP | 5.6 versus 5.5 months; HR 0.797 (95% CI 0.588–1.080); p = 0.072 |
| Meyer et al., 2017 (TACE 2 trial) | Early/intermediate | UK | DEB‐TACE plus sorafenib (n = 157) versus DEB‐TACE plus placebo (n = 156) | PFS | 7.8 versus 7.7 months; HR 1.03 (95% CI 0.75–1.42); p = 0.85 |
| Kudo et al., 2018 (ORIENTAL trial) | Early/intermediate/advanced | Japan, South Korea, Chinese Taiwan | cTACE plus orantinib (n = 445) versus cTACE plus placebo (n = 444) | OS | 31.1 versus 32.3 months; HR 1.090 (95% CI 0.878–1.352); p = 0.435 |
| Kudo et al., 2019 (TACTICS trial) | Early/intermediate/advanced | Japan | cTACE plus sorafenib (n = 80) versus cTACE (n = 76) | PFS | 25.2 versus 13.5 months; HR 0.59 (95% CI 0.41–0.87); p = 0.006 |
| Park et al., 2019 (STAH trial) | Advanced | South Korea | cTACE plus sorafenib (n = 170) versus sorafenib (n = 169) | OS | 12.8 versus 10.8 months; HR 0.91 (CI 0.69–1.21); p = 0.290 |
| Peng et al., 2022 (LAUNCH trial) | Advanced | China | TACE plus lenvatinib (n = 170) versus lenvatinib (n = 168) | OS | 17.8 versus 11.5 months; hazard ratio, 0.45; p < 0.001 |
| HAIC combined with systemic agents | |||||
| Kudo et al., 2018 (SILIUS trial) | Advanced | Japan | HAIC plus sorafenib (n = 102) versus sorafenib (n = 103) | OS | 11.8 versus 11.5 months; HR 1.009 (95% CI 0.743–1.371); p = 0.95 |
| Kondo et al., 2019 (SCOOP‐2 trial) | Early/intermediate/advanced | Japan | HAIC plus sorafenib (n = 35) versus sorafenib (n = 33) | OS | 10.0 versus 15.2 months, HR 1.08 (95% CI 0.63–0.86); p = 0.78 |
| He et al., 2021 | Advanced | China | HAIC plus sorafenib (n = 125) versus sorafenib (n = 122) | OS | 13.37 versus 7.13 months; HR 0.35 (95% CI 0.26–0.48); p < 0.001 |
| TARE combined with systemic agents | |||||
| Ricke et al., 2019 (SORAMIC trial) | Advanced | Europe, Turkey | TARE plus sorafenib (n = 216) versus sorafenib (n = 208) | OS | 12.1 versus 11.4 months; HR 1.01 (95% CI 0.81–1.25); p = 0.95 |
Abbreviations: BCLC, Barcelona clinic liver cancer; cTACE, conventional transarterial chemoembolization; DEB‐TACE, drug‐eluting bead transarterial chemoembolization; HAIC, hepatic arterial infusion chemotherapy; HR, hazard ratio; OS, overall survival; PFS, progression‐free survival; TACE, transarterial chemoembolization; TARE, yttrium‐90 transarterial radioembolization; TTP, time to progression.