Immunotherapy for hepatocellular carcinoma: A promising therapeutic option for advanced disease

Table 1 Clinical trial involving immunotherapic agents as adjuvant therapy for hepatocellular carcinoma

Trial	Included population	Immunotherapy regimen	Target	Control arm	Primary outcome	Sample size
CHECKMATE-9DX (NCT03383458)	Patients at high risk of recurrence after resection or ablation	Nivolumab	PD-1	Placebo	RFS	530
KEYNOTE-937 (NCT03867084)	Patients with complete radiological response after resection or ablation	Pembrolizumab	PD-1	Placebo	RFS, OS	950
EMERALD-2 (NCT03847428)	Patients at high risk of recurrence after resection or ablation	Durvalumab plus bevacizumab anddurvalumab plus placebo	PD-L1	Placebo plus placebo	RFS	888
IMBRAVE-050 (NCT04102098)	Patients at high risk of recurrence after resection or ablation	Atezolizumab plus bevacizumab	PD-L1	Active surveillance	RFS	662

PD-1: Programmed cell death protein 1; RFS: Recurrence-free survival; OS: Overall survival.

Table 2 Ongoing clinical trial involving immunotherapic agents as first line therapy for hepatocellular carcinoma

Trial	Immunotherapy regimen	Target	Control arm	Primary outcome	Sample size
RATIONALE-301 (NCT03412773	Tislelizumab	PD-1	Sorafenib	OS	674
CHECKMATE-9DW (NCT04039607)	Nivolumab plus ipilimumab	PD-1	Sorafenib or Lenvatinib	OS	650
COSMIC-312 (NCT03755791)	Atezolizumab plus cabozantinib	PD-L1/Tyrosine Kinase	Cabozantinib or Sorafenib	PFS, OS	740
ORIENT-32 (NCT03794440)	Sintilimab plus IBI305	PD1/VEGF	Sorafenib	OS, ORR	595
LEAP-002 (NCT03713593)	Lenvatinib plus pembrolizumab	VEGF-R/PD-1	Lenvatinib plus placebo	PFS, OS	750
HIMALAYA (NCT03298451)	Durvalumab plus tremelimumab or durvalumab	PD-L1/CTLA4	Sorafenib	OS	1504
PHOCUS (NCT02562755)	Pexa-Vec plus sorafenib	Thymidine kynase	Sorafenib	OS	459
LEAP-012 (NCT04246177)	TACE plus pembrolizumab plus lenvatinib	PD-1	TACE plus placebo plus placebo	PFS, OS	950
CHECKMATE-74W (NCT04340193)	TACE plus nivolumab plus ipilimumab	PD-1	TACE plus nivolumab plusplacebo or TACE plus placebo plus placebo	TTTP, OS	765
EMERALD-1 (NCT03778957)	TACE plus durvalumab plus; Bevacizumab or TACE plus durvalumab plus placebo	PD-L1/VEGF	TACE plus placebo plus placebo	PFS	710
TACE-3 (NCT04268888)	DEB TACE plus nivolumab	PD-1	DEB TACE	OS	522

PD-1: Programmed cell death protein 1; VEGF: Vascular Endothelial Growth Factor; CTLA-4: Cytotoxic T-Lymphocyte Antigen 4; PFS: Progression-free survival; ORR: Overall response rate; TTTP: Time to TACE progression; RFS: Recurrence-free survival; OS: Overall survival.