Table 1 Trials investigating the combination therapy of ICIs and TKIs in HCC
Trial name/identifier | Patient No. | Study type | Line | Interventions | Primary endpoint | Study status |
|---|---|---|---|---|---|---|
LEAP-002/NCT03713593 | 1097 | Phase III | First | Lenvatinib + pembrolizumab vs lenvatinib | PFS+OS | Active, not recruiting |
CheckMate 9DW/NCT04039607 | 1084 | Phase III | First | Nivolumab + ipilimumab vs lenvatinib or sorafenib | OS | Ongoing |
COSMIC-312/NCT03755791 | 740 | Phase III | First | Cabozantinib + atezolizumab vs sorafenib | PFS+OS | Ongoing |
ORIENT-32/NCT03794440 | 566 | Phase III | First | Sintilimab + IBI305 vs sorafenib | OS, ORR | Ongoing |
SHR-1210-III-310/NCT03764293 | 448 | Phase III | First | Camrelizumab + apatinib vs sorafenib | OS+PFS | Ongoing |
SHR-1210-III-305/ NCT03605706 | 448 | Phase III | First | Camrelizumab + apatinib vs FOLFOX 4 or sorafenib | OS | Ongoing |
IMMUNIB/NCT03841201 | 50 | Phase II | First | Nivolumab + lenvatinib | ORR, AE | Ongoing |
NCT03439891 | 40 | Phase II | First | Nivolumab + sorafenib | MTD, ORR | Ongoing |
NCT03211416 | 27 | Phase Ib/ II | First | Sorafenib + pembrolizumab | ORR | Ongoing |
KEEP-G 04/NCT04052152 | 20 | Phase II | First | Anlotinib + sintilimab | ORR AE | Ongoing |
VEGF Liver 100/NCT03289533 | 22 | Phase Ib | First | Avelumab + axitinib | AE | Completed |
KN/743/NCT03347292 | 57 | Phase I | First | Regorafenib + pembrolizumab | AE | Ongoing |
GOING/NCT04170556 | 60 | Phase II | Second | Regorafenib + nivolumab | AE | Ongoing |
REGOMUNE/NCT03475953 | /a | Phase I/II | Second | Regorafenib + avelumab | CR, PR | Ongoing |
NCT02423343 | /a | Phase Ib/ II | Second | Galunisertib + nivolumab | Phase Ib: MTD | Ongoing |
