Table 3.
Selected phase III studies determining the role of systemic treatment in earlier-stage hepatocellular carcinoma
| NCT number | Patient numbers | Study arm | Control arm | Primary end points | |
|---|---|---|---|---|---|
| IMbrave050 | 04102098 | 668 | Atezolizumab + bevacizumab | Active surveillance | RFS |
| EMERALD-2 | 03847428 | 877 | Durvalumab + bevacizumab | Placebo | RFS |
| Durvalumab | |||||
| CHECKMATE 9DX | 03383458 | 545 | Nivolumab | Placebo | RFS |
| KEYNOTE 937 | 03867084 | 950 | Pembrolizumab | Placebo | RFS |
| ABC-HCC | 04803994 | 434 | Atezolizumab + bevacizumab | TACE | TTF |
| RENOTACE | 04777851 | 496 | Regorafenib + nivolumab | TACE | PFS |
| TACE-3 | 04268888 | 522 | Nivolumab + TACE | TACE | OS, TTTP* |
| LEAP-012 | 04246177 | 950 | Pembrolizumab + lenvatinib + TACE | TACE | PFS, OS |
| CHECKMATE 74W | 04340193 | 765 | Nivolumab + ipilimumab + TACE | TACE | TTTP, OS |
| Nivolumab + TACE | |||||
| EMERALD-1 | 03778957 | 724 | Durvalumab + bevacizumab + TACE | TACE | PFS |
| Durvalumab + TACE | |||||
| EMERALD-3 | 05301842 | 525 | Durvalumab + tremelimumab + lenvatinib + TACE | TACE | PFS |
| Durvalumab + tremelimumab + TACE |
Note: *TTTP was the primary end point for the phase II part.
Abbreviations: NCT, National Clinical Trial; RFS, recurrence-free survival; TACE, transarterial chemoembolization; TTF, time to treatment failure; PFS, progression-free survival; TTTP, time to TACE progression.