Table 1. . Failed Phase III randomized clinical trials investigating drugs for patients with unresectable hepatocellular carcinoma not amenable for locoregional treatments.
| Name of the trial | Study drug | Therapeutic line | Primary end point |
|---|---|---|---|
| No name | Linifanib vs sorafenib | 1 | No difference in OS (HR: 1.046; 95% CI: 0.896–1.221) |
| SEARCH | Sorafenib + erlotinib vs sorafenib + placebo | 1 | No difference in OS (HR: 0.929; 95% CI: 0.781–1.106; p = 0.408) |
| No name | Sunitinib vs sorafenib | 1 | Significant inferiority in OS (HR: 1.30; 95% CI: 1.13–1.50; p = 0.014) |
| BRISK-FL | Brivanib vs sorafenib | 1 | No difference in OS (HR: 1.06; 95% CI: 0.93–1.22) |
| BRISK-PS | Brivanib vs placebo | 2 | No difference in OS (HR: 0.89; 95% CI: 0.69–1.15; p = 0.33) |
| REACH | Ramucirumab vs placebo | 2 | No difference in OS (HR: 0.87; 95% CI: 0.72–1.05; p = 0.14) |
| EVOLVE-1 | Everolimus vs placebo | 2 | No difference in OS (HR: 1.05; 95% CI: 0.86–1.27; p = 0.68) |
| POLARIS2009-001 | ADI-PEG20 vs placebo | 2 | No difference in OS (HR: 1.02; 95% CI: 0.85–1.23; p = 0.88) |
| METIV-HCC | Tivantinib vs placebo | 2 | No difference in OS (HR: 0.97; 95% CI: 0.75–1.25; p = 0.81) |
| JET-HCC | Tivantinib vs placebo | 2 | No difference in PFS (further data still not released) |
HR: Hazard ratio; OS: Overall survival; PFS: Progression-free survival.