Table 3.
Ongoing clinical trials of ICI-based approaches in HCC.
| Trial Name and ID | Cancer Type | Estimated Enrollment | Targeting Mechanism | Control Arm | Phase | Start and Completion Dates | Primary Measures |
|---|---|---|---|---|---|---|---|
| RATIONALE—301 [64] NCT03412773 |
HCC | December 2017 | Tislelizumab (anti-PD-1 antibody) | Sorafenib | III | December 2017 July 2023 |
OS |
| Checkmate 9DW [65] NCT04039607 |
HCC | September 2019 | Nivolumab + Ipilimumab | Sorafenib or lenvatinib | III | September 2019 June 2025 |
OS |
| NCT03764293 [45] (CARES-310) | Locally advanced or metastatic and unresectable HCC | June 2019 | Camrelizumab (anti-PD-1 antibody) + Apatinib (VEGF inhibitor) | Sorafenib | III | June 2019 April 2023 |
OS PFS |
| DEDUCTIVE [62] NCT03970616 |
Advanced HCC | September 2019 | Tivozanib (selective VEGFR 1,2,3 TKI) + Durvalumab (PD-L1 inhibitor) | N/A | 1/IIb | September 2019 March 2023 |
TEAEs |
| NCT04183088 [63] | Advanced HCC | December 2020 | Tislelizumab (anti-PD-1 antibody) + regorafenib (TKI) | N/A | II | December 2020 March 2025 |
TRAE ORR PFS |
| NCT04401813 [66] | Advanced HCC | June 2020 | IBI308 (anti-CTLA4 antibody) + Sintilizumab (anti-PD-1 antibody) | N/A | I | June 2020 April 2023 |
AE ORR |
| NCT04212221 [67] | Advanced HCC | April 2020 | MGD013 (anti PD 1 antiobdy and anti-LAG-3 antibody) + Brivanib | N/A | I/II | Completed Pending results | DLTs ORR |
| NCT03680508 [68] | Advanced HCC | December 2019 | Cobolimab (TIM-3 binding antibody) + Dostarlimab (anti PD-1 antibody) | N/A | II | December 2019 October 2025 |
ORR |
| NCT03841201 [69] | Advanced HCC | June 2019 | Lenvatinib (TKI) + Nivolumab (anti-PD-1 antibody) | N/A | II | June 2019 March 2023 |
ORR AE SAE |
| RENOBATE [70] NCT04310709 |
Advanced HCC | June 2020 | Regorafenib + Nivolumab | Completed Pending results |
Response Rate | ||
| ARYA-1 [71] NCT04502082 |
Advanced HCC | April 2021 | ET140203 autologous T cell product | N/A | I/II | April 2021 June 2024 |
Incidence of AE and severity rates of AE Incidence rates of DLT RP2D |
| TRIPLET [72] NCT05665348 |
HCC—Hepatocellular Carcinoma | September 2021 | Atezolizumab (anti-PD-L1 antibody) + Bevacizumab (VEGF inhibitor) + Ipilimumab (anti-CTLA-4 antibody) | Atezolizumab + Bevacizumab | II/III | September 2021 April 2026 |
Objective response Overall survival |
| NCT05022927 [73] | Advanced HCC | June 2021 | ERY974 + Tocilicumab + Atezolizumab + Bevacizumab | N/A | I | June 2021 September 2024 |
Incidence of treatment-emergent adverse events (TEAE) |
| The PNeoVCA Study [74] NCT05269381 |
Various advanced solid tumors including HCC | March 2022 | Cyclophosphamide (alkylating agent) + Neoantigen vaccine (containing sargramostim (GM-CSF)) + Pembrolizumab (anti-PD-1 antibody) | N/A | I | March 2022 February 2025 |
Incidence of AE |
| RELATIVITY—106 [75] NCT05337137 |
Advanced HCC | April 2022 | Relatinib + Nivolumab + Bevacizumab | Nivolumab + Bevacizumab | 1/2 | April 2022 March 2023 |
Incidence of DLT PFS |