Table 3 The major ICI-based clinical trials in the perioperative treatment of hepatocellular carcinoma
Study | Treatment setting | Drug | Phase | n | Primary endpoint | Efficacy |
|---|---|---|---|---|---|---|
IMbrave050 [128] | Adjuvant | Atezolizumab + bevacizumab vs. placebo | III | 668 | RFS | Improved RFS HR = 0.72 (95% CI 0.53–0.98; p = 0.012) |
Checkmate 9DX [142] | Adjuvant | Nivolumab vs. placebo | III | 545 | RFS | NA |
EMERALD-2 [143] | Adjuvant | Durvalumab ± bevacizumab vs. placebo | III | 908 | RFS | NA |
KEYNOTE-937 [144] | Adjuvant | Pembrolizumab vs. placebo | III | 950 | RFS/OS | NA |
JUPITER 04 | Adjuvant | Toripalimab vs. placebo | II/III | 402 | RFS | NA |
NCT04639180 | Adjuvant | Camrelizumab + Rivoceranib vs. active surveillance | III | 687 | RFS | NA |
Wang K, et al. [145] | Adjuvant | Sintilimab vs. active surveillance | II | 198 | RFS | 27.7 vs. 15.5 mo; HR = 0.534 (95% CI 0.360–0.792; p = 0.002) |
NCT05613478 | Neoadjuvant | Camrelizumab + apatinib + TACE | III | 130 | RFS | NA |
NCT05250843 | Neoadjuvant | Sintilimab + lenvatinib + TACE/HAIC | II/III | 90 | RFS | NA |
HCC-009 [146] | Neoadjuvant | Camrelizumab + apatinib | II | 20 | MPR | ORR = 16.7% 1-year RFS = 53.85% |
NCT03222076 [147] | Neoadjuvant/ adjuvant | Nivolumab ± ipilimumab | II | 30 | AEs | mRFS = 19.53 vs. 9.4mo |
NIVOLEP | Neoadjuvant | Nivolumab | II | 43 | RFS | NA |
NCT04615143 | Neoadjuvant | Tislelizumab ± levatinib | II | 80 | DFS | NA |
NCT03867370 | Neoadjuvant | Toripalimab ± levatinib | II | 40 | MPR | NA |
NCT05056337 | Conversion | Toripalimab + Lenvatinib + TACE | III | 220 | ORR | NA |
LEN-TAC | Conversion | Camrelizumab + Lenvatinib + TACE | III | 168 | Conversion rate/OS | NA |
NCT04042805 [151] | Conversion | Sintilimab + lenvatinib | II | 36 | ORR | ORR = 35% Conversion rate = 27% |
NCT04843943 [152] | Conversion | Sintilimab + bevacizumab | II | 30 | AEs/EFS | ORR = 23.3% Conversion rate = 43% |
NCT05029973 [153] | Conversion | Sintilimab + bevacizumab + HAIC | II | 30 | ORR | ORR = 66.7% Conversion rate = 47% |