Table 6.

Treatment-Related Adverse Events ^a .

Adverse event	Toripalimab plus HAIC (n = 53)		Lenvatinib (n = 65)		P-value
	Any grade (%)	Grade 3 to 4 (%)	Any grade (%)	Grade 3 to 4 (%)	Any grade	Grade 3 to 4
Neutropenia	24 (45.3%)	3 (5.7%)	11 (16.9%)	1 (1.5%)	0.001	0.47
Thrombocytopenia	16 (30.2%)	2 (3.8%)	10 (15.4%)	1 (1.5%)	0.054	0.86
Fatigue	36 (67.9%)	3 (5.7%)	26 (40%)	2 (3.1%)	<0.001	0.71
Hypertension	2 (3.8%)	0	23 (35.4%)	7 (10.8%)	<0.001	0.02
Weight loss	18 (34.0%)	2 (3.8%)	19 (29.2%)	1 (1.5%)	0.58	0.44
Hypothyroidism	2 (3.8%)	0	10 (15.4%)	0	0.04	−
Hand–foot skin reaction	0	0	15 (23.1%)	2 (3.1%)	<0.001	0.50
Rash	4 (7.5%)	0	8 (12.3%)	0	0.45	−
Nausea	16 (30.2%)	1 (1.9%)	12 (18.5%)	0	0.14	0.92
Vomiting	14 (26.4%)	2 (3.8%)	11 (16.9%)	1 (1.5%)	0.21	0.59
Diarrhea	14 (26.4%)	1 (1.9%)	23 (35.4%)	2 (3.1%)	0.3	1.00
Abdominal pain	17 (32.1%)	2 (3.8%)	12 (18.5%)	0	0.09	0.2
Sensory neuropathy	17 (32.1%)	0	0	0	<0.001	−
Proteinuria	7 (13.2%)	1 (1.9%)	15 (23.1%)	2 (3.1%)	0.17	1.00
Elevated ALT	36 (67.9%)	6 (7.5%)	19 (29.2%)	2 (3.1%)	<0.001	0.14
Elevated AST	38 (71.7%)	7 (13.2)	23 (35.4%)	3 (4.6%)	<0.001	0.18
Hyperbilirubinemia	20 (37.8%)	2 (3.8%)	17 (26.2%)	1 (1.5%)	0.18	0.59
Hypoalbuminemia	37 (69.8%)	1 (1.9%)	3 (3.4%)	0	<0.001	0.92

Abbreviations: HAIC, hepatic arterial infusion chemotherapy; ALT, alanine aminotransferase; AST, aspartate aminotransferase.

P-value was calculated by a 2-sided chi-square test.

^a Listed are adverse events, as defined by the National Cancer Institute Common Terminology Criteria (version 4.03), that occurred in at least 10% of patients in either study group.