Table 1.
Principal ongoing clinical trials with immune checkpoint inhibitors in advanced HCC.
| Study | Treatment (and Control) | Target | Setting/Target Patients | Start Date |
|---|---|---|---|---|
| NCT03638141 | durvalumab and tremelimumab + DEB-TACE | Anti-PD-L1+ anti-CTLA-4 | Intermediate stage/30 pts | 2 October 2019 |
| NCT04273100 | PD-1 mAb + Lenvatinib + TACE | Anti-PD-1+ MKI | Intermediate stage/56 pts | 14 November 2019 |
| NCT04522544 | Durvalumab and tremelimumab + SIRT or TACE | Anti-PD-L1+ anti-CTLA-4 | Intermediate stage/84 pts | 15 December 2020 |
| NCT04268888 | Nivolumab + TACE/TAE | Anti-PD-1 | Intermediate stage/522 pts | 8 May 2019 |
| EMERALD-1 (NCT03778957) |
Durvalumab +TACE versus durvalumab and bevacizumab + TACE versus placebo + TACE | Anti-PD-L1, anti-PD-L1 + anti-VEGF | Locoregional HCC/710 | 30 November 2018 |
| LEAP012 (NCT04246177) |
pembrolizumab + lenvatinib + TACE versus placebo + TACE | Anti-PD-1 + MKI | Intermediate stage /950 pts | 22 May 2020 |
| PETAL (NCT03397654) |
Pembrolizumab following TACE | anti-PD-1 | Intermediate stage/26 pts | 28 January 2018 |
| NCT03316872 | Pembrolizumab + SBRT | Anti-PD-1 | 2nd line setting/30 pts | 15 February 2018 |
| NCT02837029 | nivolumab+ SIRT | Anti-PD-1 | Advanced HCC/27 pts | July 2016 |
| NCT03033446 in Asian patients | nivolumab + SIRT | Anti-PD-1 | Advanced HCC/40 pts | 20 December 2016 |
| NCT03380130 | nivolumab after SIRT | Anti-PD-1 | Advanced HCC/41 pts | 11 September 2017 |
| NCT02988440 | Sorafenib + spartalizumab | MKI + anti-PD-1 | Advanced HCC/20 pts | 20 April 2017 |
| NCT03347292 | Regorafenib + pembrolizumab | MKI + anti-PD-1 | 1st line setting/57 pts | 18 June 2018 |
| Regomune (NCT03475953) Expansion cohort D |
Regorafenib + avelumab in solid tumors | MKI + anti-PD-1 | 2nd line setting/482 patients | 4 May 2018 |
| Checkmate 040NCT01658878 |
Nivolumab; nivolumab + ipilimumab; Cabozantinib+ nivolumab; Cabozantinib + nivolumab + ipilimumab | Anti-PD-1, anti-PD-1+anti-CTLA-4; MKI + anti-PD-1; MKI + anti-PD-1 + anti-CTLA-4 | Advanced HCC: uninfected HCC pts, HCV-infected HCC pts, and HBV-infected pts 659 patients |
30 October 2012 |
| NCT03764293 | camrelizumab + apatinib versus sorafenib | MKI + anti-PD-1 | 1st line setting/510 pts | 10 June 2019 |
| COSMIC-312 (NCT03755791) | Cabozantinib atezolizumab versus sorafenib | MKI + anti-PD-L1 | 1st line setting/740 pts | 10 December 2018 |
| NCT03605706 | Camrelizumab + folfox | Anti-PD-1 | 1st line setting/396 pts | 31 May 2019 |
| HIMALAYA (NCT03298451) |
Tremelimumab + durvalumab versus sorafenib | Anti-CTLA4 Ab + anti-PD-L1 | 1st line setting/1504 pts | 11 October 2017 |
| LEAP-002 (NCT03713593) |
Lenvatinib plus pembrolizumab versus lenvatinib | MKI + anti-PD-1 versus MKI | 1st line setting/750 pts | 31 December 2018 |
| NCT03228667 | N-803 + Durvalumab + PD-L1 t-haNK | Anti-PD-1/PD-L1 | PD to ICIs/145 pts | 11 December 2018 |
PD-1: programmed cell death-1, PD-L1: programmed cell death-ligand1, MKI: Multikinase inhibitor, VEGF: vascular endothelial growth factor; SBRT: Stereotactic Body Radiation Therapy, SIRT: Selective Internal Radiation Therapy, TACE: Transcatheter Arterial Chemoembolization, HCV: Hepatitis C virus, HBV: Hepatitis B virus, PTS: patients, CR: complete response, PD: progression disease, ICI: immune checkpoint inhibitor.