Table 1.
Clinical trials of immune checkpoint inhibitor monotherapy as first- or second-line for patients with advanced or unresectable hepatocellular carcinoma.
| Drug | Trials | Phase | Design | Follow-up duration (months) | ORR according to RECIST 1.1(%) | Median survival time (months) | Median PFS time(months) | AE of grade ≥3 (%) |
|---|---|---|---|---|---|---|---|---|
| First-line | ||||||||
| Nivolumab | CheckMate 040 (34) | I/II | Nivolumab dose-expansion 0.1–10mg/kg iv q2w (n=214) vs Nivolumab dose-escalation 3 mg/kg iv q2w (n=48) | NR | 19.6 vs 14.6 | Not reached vs 15.0 | 4.0 vs 3.4 | 18.7 vs 25.0 |
| Nivolumab | CheckMate 459 (35) | III | Nivolumab 240 mg iv q2w (n=371) vs Sorafenib 400 mg oral bid (n=372) | 22.8 | 15.4 vs 7.0 | 16.4 vs 14.7 | 3.7 vs 3.8 | 21.8 vs 48.1 |
| Second-line | ||||||||
| Pembrolizumab | KEYNOTE 224 (36) | II | Pembrolizumab 200 mg iv q3w (n=104) | 12.3 | 17.3 | 12.9 | 4.9 | 24.0 |
| Pembrolizumab | KEYNOTE 240 (37) | III | Pembrolizumab 200 mg iv q3w (n=278) vs Placebo 200 mg iv q3w (n=135) | 13.8 vs 10.6 | 18.3 vs 4.4 | 13.9 vs 10.6 | 3.0 vs 2.8 | 52.7 vs 46.3 |
| Camrelizumab | NCT02989922 (38) | II | Camrelizumab 3 mg/kg oral q2w (n=109) vs Camrelizumab 3 mg/kg oral q3w (n=108) | 12.5 | 11.9 vs 17.6 | 14.2 vs 13.2 | 2.3 vs 2.0 | 22.0 |
| Durvalumab | NCT01693562 (39) | I/II | Durvalumab10 mg/kg oral q2w (n=40) | 6.0 | 10.3 | 13.2 | NR | 20.0 |
AE, adverse events; bid, every two days; iv, intravenous; NR, not reported; ORR, objective response rate; PFS, progression-free survival; qd, every day; q2w, every 2 weeks; q3w, every 3 weeks.