Table 3.

Ongoing Clinical Trials for Preoperative Immunotherapy

NCT	ICI Regime	Key Inclusion Criteria	Interventions	Primary Endpoints	N	Phase
NCT03510871	Nivolumab 3 mg/kg Q3W Ipilimumab 1 mg/kg Q3W	Potentially eligible for resection, high risk for recurrence	Tumor assessment after 2 and 4 cycles, eligible patients undergo surgery	Tumor shrinkage according to RECIST	40	II
NCT05471674	Nivolumab 3 mg/kg Q2W	Borderline resectable tumor	Resection after 3 cycles of nivolumab	Pathological tumour response rate	20	II
NCT03299946	Cabozantinib 40mg QD Nivolumab 240mg Q2W	Locally advanced tumor	Combined treatment with nivolumab/cabozantinib for 8 weeks followed by resection	Safety	15	I
NCT03916627	Cemiplimab	Surgical candidate for tumor resection	Treatment prior to and post resection	Significant tumor necrosis	88	II
NCT04123379	Nivolumab BMS-813160 (CCR2/5-inhibitor) BMS-986253 (anti-IL-8)	Surgical candidate for tumor resection	Cohort A: Nivolumab Q4W 2 cycles prior to and 3 cycles after resection Cohort B: additionally BMS-813160 BD during 28 days prior to resection Cohort C: additionally BMS-986253 2400mg as single dose	Significant tumor necrosis	50	II
NCT03867370	Lenvatinib Toripalimab	Technically resectable tumor	Cohort A: neoadjuvant toripalimab 480mg as a single dose; adjuvant toripalimab 240mg Q3W for 48 weeks Cohort B: additionally lenvatinib 8–12mg QD neoadjuvant and adjuvant Cohort C: additionally lenvatinib 8–12mg QD only neoadjuvant, but not adjuvant	Pathological response rate	40	Ib/II
NCT04850040	Camrelizumab 200mg Q2W Apatinib Mesylate 250mg QD Oxaliplatin 85 mg/m2 Q2W	Locally advanced potentially resectable tumors, tumor ruptured, adjacent organ invasion	Neoadjuvant combination therapy followed by resection	Major pathological response	15	II
NCT04615143	Lenvatinib 8–12mg QD Tislelizumab 200mg Q3W	Tumor recurrence after initial curative treatment	Cohort A: Tislelizumab 2 cycles neoadjuvant; up to 1 year adjuvant Cohort B: additionally lenvatinib (neoadjuvant for 28 days; adjuvant up to 1 year)	Recurrence -free survival	80	II
NCT05194293	Regorafenib QD Durvalumab Q3W	Potentially resectable high risk tumor T1b / T2 / T3a	Regorafenib on days 1–21 and durvalumab on day 1. Cycle repeats every 28 days until surgery or for up to 2 years post-inclusion	Objective response rate at week 16	27	II
NCT04888546	TQB2450 (anti-PD-L1)1200mg Q3W Anlotinib 10mg QD	Tumor with a high risk of recurrence or metastasis	Combination treatment prior to resection	Pathological complete response rate Overall response rate	20	Ib/II
NCT04224480	Pembrolizumab 200mg Q3W	Technically resectable tumor	Neoadjuvant cycle 4 weeks prior to resection, adjuvant cycles starting 4 weeks after resection up to 12 months	Recurrence rate within 2 years after resection	45	I
NCT05389527	Lenvatinib 8–12mg QD Pembrolizumab 200mg Q3W	Technically resectable tumor	Resection after 3 neoadjuvant cycles; adjuvant administration for up to 1 year	Major pathological response	43	II
NCT04930315	Camrelizumab 200mg Q2W Apatinib 250mg QD	Technically resectable tumor BCLC stage B / C or CNLC stage IIa-IIIb	Cohort A: neoadjuvant 4 cycles camrelizumab + 3 cycles apatinib; adjuvant 8 cycles camrelizumab Cohort B: adjuvant 12 cycles camrelizumab	1-year tumor recurrence-free rate	78	II
NCT05185739	Lenvatinib 8–12mg QD Pembrolizumab 200mg Q3W	Single tumour any size (if no cirrhosis), tumour ≤ 5cm (if cirrhotic)	6 weeks of neoadjuvant therapy, randomization 1:1:1 to one of 3 groups: - Pembrolizumab, - Lenvatinib - Pembrolizumab/Llenvatinib followed by12 months treatment with post-operative Pembrolizumab	Major pathological response rate	60	II
NCT04954339	Atezolizumab 1200 mg Q3W Bevacizumab 15 mg/kg Q3W	Potentially resectable tumor BCLC stage B/C	2 cycles neoadjuvant, 4 cycles adjuvant	Rate of pathological complete response	45	II
NCT04658147	Nivolumab 480mg Q4W Relatlimab 480 mg Q4W	Technically resectable tumor	Randomization to 12 months of neoadjuvant: - Nivolumab - Nivolumab/Rrelatlimab	Number of patients who complete neoadjuvant treatment and proceed to surgery within 4 years	20	I
NCT04721132	Atezolizumab Bevazizumab	Resectable tumor	3 cycles neoadjuvant, surgery during week 21	Rate of pathological complete response	30	II