Stereotactic body radiotherapy combined with sintilimab in patients with recurrent or oligometastatic hepatocellular carcinoma: A phase II clinical trial

Table 1 Patient demographics and baseline clinical characteristics

Characteristics	n = 25
Age, years, median (range)	64 (33-71)
Male sex, n (%)	24 (96)
Etiology, n (%)
Hepatitis B infection	24 (96)
Others	1 (4)
ECOG performance status, n (%)
0	19 (76)
1	6 (24)
Child-Pugh class A, n (%)	25 (100)
BCLC C stage, n (%)	25 (100)
Site of recurrence, n (%)
Intrahepatic	19 (76)
Extrahepatic	6 (24)
Both Intra-Extrahepatic	2 (8)
Target tumor size, cm, median (range)	2.0 (1.0-7.4)
Tumor number, n (%)
1	19 (76)
2	5 (25)
3	1 (4)
Serum AFP ≥ 400 ng/mL, n (%)	3 (12)
Prior therapy, n (%)
Surgery	17 (68)
Ablation	9 (36)
TACE	13 (52)

AFP: α-fetoprotein; BCLC: Barcelona Clinic Liver Cancer; ECOG: Eastern Cooperative Oncology Group; TACE: Trans-arterial chemoembolization.

Table 2 Summary of radiographic response per response evaluation criteria in solid tumors version 1.1

Variable	n = 25
Best overall response, n (%)
Complete response	17 (68)
Partial response	7 (28)
Stable disease	0
Progressive disease	1 (4)
Objective response rate, n (%)	24 (96)
Disease control rate, n (%)	24 (96)
1 yr local control rate, n (%)	25 (100)

Table 3 Treatment-related adverse events

Treatment-related adverse events	Any grade	Grade 1	Grade 2	Grade 3
All adverse events, n (%)	22 (88)	17 (68)	14 (56)	3 (12)
Decreased lymphocyte count	14 (56)	7 (28)	7 (28)	0
Increased GGT	7 (28)	3 (12)	3 (12)	1 (4)
Decreased platelet count	5 (20)	0	4 (16)	1 (4)
Increased blood bilirubin	5 (20)	4 (16)	1 (4)	0
Rash	4 (16)	2 (8)	2 (8)	0
Increased ALT	2 (8)	1 (4)	1 (4)	0
Increased AST	2 (8)	2 (8)	0	0
Myositis	2 (8)	0	1 (4)	1 (4)
Abnormal liver function	2 (8)	1 (4)	1 (4)	0
Paronychia	2 (8)	2 (8)	0	0
Jaundice	2 (8)	0	2 (8)	0
Decreased white blood cell count	1 (4)	1 (4)	0	0
Decreased neutrophil count	1 (4)	1 (4)	0	0
Ascites	1 (4)	0	1 (4)	0
Arthritis	1 (4)	0	1 (4)	0
Pneumonia	1 (4)	0	1 (4)	0
Myocarditis	1 (4)	1 (4)	0	0
Dry eye	1 (4)	1 (4)	0	0

GGT: Gamma-glutamyl transpeptidase; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase.