Table 2.

Current clinicals trials on systemic immunotherapy in advanced HCC.

Trial	Identifier	Phase	BCLC Stage	Treatment Arms	Primary Endpoint(s)	Setting
CheckMate 9DW	NCT04039607	Phase 3	C	Nivolumab + ipilimumab Sorafenib or lenvatinib	OS	First-line
COSMIC-312	NCT03755791	Phase 3	B or C	Cabozantinib + atezolizumab Sorafenib Cabozantinib	PFS per RECIST 1.1 OS	First-line
HIMALAYA	NCT03298451	Phase 3	B or C	Durvalumab Durvalumab + trevelimumab (2 regimens) Sorafenib	OS	First-line
LEAP-002	NCT03713593	Phase 3	B or C	Lenvatinib + pembrolizumab Lenvatinib	PFS per RECIST 1.1 OS	First-line
RATIONALE-301	NCT03412773	Phase 3	B or C	Tislelizumab Sorafenib	OS	First-line
N/A	NCT03764293	Phase 3	B or C	Camrelizumab (SHR-1210) + apatinib Sorafenib	PFS OS	First-line
Bayer 19497	NCT03347292	Phase 1b/2	B or C	Regorafenib + pembrolizumab	Safety	First-line
GOING	NCT04170556	Phase 1/2	BCLC C	Regorafenib (monotherapy for the first 8 weeks) + nivolumab	Safety	Second-line
ORIENT-32	NCT03794440	Phase 2/3	B or C	Sintilimab + IBI305 Sorafenib	PFS per RECIST 1.1 OS	First-line
RENOBATE	NCT04310709	Phase 2	B or C	Regorafenib + nivolumab	ORR per RECIST 1.1	First-line
N/A	NCT04183088	Phase 2	B or C	Part 1: Regorafenib + tislelizumab Part 2: Regorafenib + tislelizumab Regorafenib	Part 1: Safety Part 2: PFS per RECIST 1.1 ORR per RECIST 1.1	First-line
N/A	NCT04442581	Phase 2	B or C	Cabozantinib + pembrolizumab	ORR per RECIST 1.1	First-line
N/A	NCT03941873	Phase 1/2	B or C	Phase 1: Sitravatinib Sitravatinib + tislelizumab Phase 2: Sitravatinib Sitravatinib + tislelizumab	Phase 1: Safety Phase 2: ORR per RECIST 1.1	First- and later line

BCLC, Barcelona Clinic Liver Cancer; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; RECIST, Response Evaluation Criteria in Solid Tumours.