Table 2.
Clinical trials for second-line treatment of advanced HCC.
| Study Name | Design | Met Primary Endpoint(s) | Patients (n) | TTP/PFS (months) | mOS (months) |
|---|---|---|---|---|---|
| 2nd Line Setting | |||||
| RESORCE | Regorafenib vs. placebo | Yes | Regorafenib (379) Placebo (194) |
3.2 vs. 1.5 HR = 0.44 95% CI: 0.36–0.55 p < 0.0001 |
10.6 vs. 7.8 HR = 0.63 95% CI: 0.50–0.79 p < 0.0001 |
| CELESTIAL | Cabozantinib vs. placebo | Yes | Cabozantinib (470) Placebo (237) |
5.2 vs. 1.9 * HR = 0.44 95% CI: 0.36–0.52 p < 0.001 |
10.2 vs. 8.0 HR = 0.76 95% CI: 0.63–0.92 p = 0.005 |
| REACH-2 | Ramucirumab vs. placebo | Yes | Ramucirumab (197) Placebo (95) |
3.0 vs. 1.6 HR = 0.43 95% CI: 0.31–0.58 p < 0.0001 |
8.5 vs. 7.3 HR = 0.71 95% CI: 0.53–0.94 p = 0.020 |
| CheckMate 040 | Nivolumab phase I/II | Yes | Dose-escalation (48) Dose-expansion (214) |
Dose-escalation: 3.4 Dose-expansion: 4.1 |
Dose-escalation: 15.0 Dose-expansion: NR |
| KEYNOTE-224 | Pembrolizumab phase II | Yes | Pembrolizumab (104) | 4.9 95% CI: 3.9–8.0 |
12.9 95% CI: 9.7–15.5 |
| KEYNOTE-240 | Pembrolizumab vs. placebo | No | Not provided | Not provided HR = 0.78 95% CI: 0.61–0.99 p = 0.021 |
Not provided HR = 0.78 95% CI: 0.61–1.00 p = 0.024 |
* Progression-Free Survival (PFS); NR: not reached.