Immunotherapy for advanced or recurrent hepatocellular carcinoma

Table 4 Ongoing phase I-III trials testing immune checkpoint inhibitors in advanced hepatocellular carcinoma

Drugs	Other treatment	Targets	Trial identifier	Patient group	Status	n	Estimated completion date	Phase	Setting
Single ICI
Pembrolizumab	Placebo	PD-1	NCT03062358	Advanced HCC	Active, not recruiting	454	June 30, 2023	III	2L
Tislelizumab	vs Sorafenib	PD-1	NCT03412773	Advanced HCC	Active, not recruiting	674	May 1, 2022	III	1L
Durvalumab	No	PD-L1	NCT04294498	Advanced HCC	Recruiting	43	December 31, 2023	II	2L
Tislelizumab	vs Sorafenib	PD-1	NCT03419897	Unresectable HCC	Active, not recruiting	249	June 30, 2022	II	2L
Combination of ICIs
Nivolumab + ipilimumab	vs Sorafenib and lenvatinib	CTLA-4, PD-1	NCT04039607	Advanced HCC	Recruiting	728	September 30, 2019	III	1L
Sintilimab + IBI310	vs Sorafenib	PD-1, CTLA-4	NCT04720716	Advanced HCC	Recruiting	490	February 7, 2021	III	1L
Combination of ICIs and antiangiogenic drugs
Nivolumab + regorafenib	No	PD-1, VEGFR	NCT04310709	Unresectable HCC	Recruiting	42	May 30, 2023	II	1L
Pembrolizumab + lenvatinib	Placebo and lenvatinib	PD-1, VEGFR	NCT03713593	Advanced HCC	Recruiting	750	December 31, 2023	III	1L
Pembrolizumab + futibatinib	No	PD-1, FGFR	NCT04828486	Advanced HCC	Recruiting	25	May 6, 2024	II	2L
Pembrolizumab + regorafenib	No	PD-1, VEGFR	NCT03347292	HCC	Active, not recruiting	57	September 26, 2022	I	1L
Pembrolizumab + sorafenib	No	PD-1, VEGFR	NCT03211416	Advanced or metastatic HCC	Recruiting	41	December 7, 2022	I/II	1L
Pembrolizumab + cabozantinib	No	PD-1 VEGFR	NCT04442581	Advanced HCC	Recruiting	29	September 13, 2024	II	1L
Camrelizumab + apatinib	No	PD-1, VEGFR	NCT04826406	HCC	Recruiting	40	August 30, 2023	II	1L
Camrelizumab + lenvatinib	No	PD-1, VEGFR	NCT04443309	Advanced HCC	Recruiting	53	August 1, 2023	I/II	1L
Camrelizumab + apatinib	vs Sorafenib	PD-1 VEGFR	NCT03764293	Advanced HCC	Active, not recruiting	543	June 1, 2022	III	1L
Toripalimab + lenvatinib	No	PD-1, VEGFR	NCT04368078	Advanced HCC	Recruiting	76	April 1, 2023	II	2L
Tislelizumab + regorafenib	No	PD-1, VEGFR	NCT04183088	Advanced HCC	Recruiting	125	March 1, 2025	II	1L
Tislelizumab + lenvatinib	No	PD-1, VEGFR	NCT04401800	Locally advanced or Unresectable HCC	Recruiting	66	December 1, 2022	II	1L
Sintilimab + lenvatinib	No	PD-1, VEGFR	NCT04042805	Advanced HCC	Recruiting	36	August 30, 2024	II	1L
Sintilimab + anlotinib	No	PD-1, VEGFR	NCT04052152	Advanced HCC	Recruiting	20	December 30, 2021	II	1L
Sintilimab + IBI305	vs Sorafenib	PD-1, VEGFR	NCT03794440	Advanced HCC	Active, not recruiting	595	December 1, 2022	II/III	1L
Sintilimab + regorafenib	vs Regorafenib	PD-1, VEGFR	NCT04718909	Unresectable HCC	Recruiting	180	December 31, 2022	II	1L
Sintilimab + donafenib	No	PD-1, VEGFR	NCT05162352	Advanced HCC	Recruiting	30	May 1, 2023	II	1L
Atezolizumab + lenvatinib or sorafenib	vs Sorafenib or lenvatinib	PD-L1, VEGFR	NCT04770896	Unresectable HCC	Recruiting	554	October 8, 2024	III	2L
Atezolizumab + bevacizumab	No	PD-L1, VEGFR	NCT04829383	Unresectable HCC	Recruiting	50	July 1, 2024	II	1L
Atezolizumab + bevacizumab	No	PD-L1, VEGFR	NCT04732286	Unresectable HCC	Active, not recruiting	100	September 25, 2023	III	1L
Atezolizumab + bevacizumab	No	PD-L1, VEGFR	NCT04487067	Unresectable HCC	Active, not recruiting	152	July 31, 2023	IIIb	1L
Durvalumab + tivozanib	No	PD-L1, VEGFR	NCT03970616	Advanced HCC	Recruiting	42	August 1, 2022	I/II	Mix
Durvalumab + lenvatinib	No	PD-L1, VEGFR	NCT05312216	Unresectable HCC	Not yet recruiting	25	April 1, 2022	II	1L
Durvalumab + bevacizumab	Placebo	PD-L1, VEGFR	NCT03847428	High risk of recurrence HCC	Active, not recruiting	877	May 31, 2024	III	1L

1L: First-line therapy; 2L: Second-line therapy; CTLA-4: Cytotoxic T lymphocyte-associated antigen 4; FGFR: Fibroblast growth factor receptor; HCC: Hepatocellular carcinoma; ICI: Immune checkpoint inhibitor; NR: Not reached; PD-1: Programmed cell death protein 1; PD-L1: Programmed death ligand 1; VEGFR: Vascular endothelial growth factor receptor.