Table 1.
Phase 2 or 3 clinical trials of immune modulators in adjuvant setting after curative resection or radiofrequency ablation of HCC
Setting | Trial identifier* | Agents (generic name) | Agents (type) | Number of participants† |
---|---|---|---|---|
Monotherapy | ||||
Phase 3 | NCT00149565 | Interferon alfa-2b | IFNα-2b | 268 |
Phase 3 | NCT03383458 (CheckMate 9DX) | Nivolumab | Anti-PD-1 antibody | 530 |
Phase 3 | NCT03867084 (KEYNOTE-937) | Pembrolizumab | Anti-PD-1 antibody | 950 |
Phase 2/3 | NCT03859128 (JUPITER 04) | Toripalimab | Anti-PD-1 antibody | 402 |
Phase 2 | UMIN000026648 (NIVOLVE) | Nivolumab | Anti-PD-1 antibody | 55 |
Combinations | ||||
Phase 3 | NCT03847428 (EMERALD-2) | Durvalumab±bevacizumab | Anti-PD-L1 antibody±anti-VEGFR2 antibody | 888 |
Phase 3 | NCT04102098 (IMbrave050) | Atezolizumab±bevacizumab | Anti-PD-L1 antibody±anti-VEGFR2 antibody | 662 |
Phase 2 | NCT03222076‡ | Nivolumab+ipilimumab | Anti-PD-1 antibody+anti-CTLA-4 antibody | 30 |
HCC, hepatocellular carcinoma; IFN, interferon; PD-1, programmed cell death-1; PD-L1, programmed cell death-ligand 1; VEGFR2, vascular endothelial growth factor receptor 2 ; CTLA-4, cytotoxic T-lymphocyte antigen-4.
The adjuvant IFNα-2b did not reduce the postoperative recurrence of viral hepatitis-related HCC (NCT00149565). Other trials including immune checkpoint inhibitors are currently ongoing.
Number of estimated enrollments.
Inclusion criteria show resectable hepatocellular carcinoma.