Efficacy and safety of surufatinib and anti-PD-L1 therapy in combination with hepatic arterial infusion chemotherapy for unresectable intrahepatic cholangiocarcinoma

Table 1 Baseline clinical characteristics of included patients (n = 40), median (interquartile range)/mean ± SD

Characteristics	Patients
Gender
Male	23
Female	17
Age	55.5 (30-72)/55.4 ± 10.5
Child-Pugh grade
A	39
B	1
Hepatitis virus infection
HBV	17
HCV	1
None	22
Tumor size, cm	7.8 (2.4-14.4)/7.6 ± 2.7
≤ 5	7
> 5	33
≤ 7	16
> 7	24
Tumor number
Single	14
Multiple	26
Tumor distribution
Uni-lobe	23
Bi-lobe	17
Vascular invasion
Absence	29
Presence	11
LN metastasis
Absence	22
Presence	18
Distant metastasis
Absence	33
Presence	7
TNM stage
I-II	10
IIIb	23
IV	7
CA19-9, U/mL
≤ 40	14
> 40	26
WBC, × 109/L	8.8 (6.8-9.7)
NE, × 109/L	6.0 (4.4-6.9)
Hgb, g/L	137.0 (126.5-147.0)
PLT, × 109/L	271.0 (207.8-299.8)
ALT, U/L	21.8 (17.1-33.9)
ALB, g/L	44.9 (42.7-46.7)
TBil, μmol/L	11.6 (9.8-14.4)
PT, seconds	11.5 (10.8-12.2)
CRE, μmol/L	68.2 (55.1-81.4)

HBV: Hepatitis B virus; HCV: Hepatitis C virus; LN: Lymph node; CA19-9: Carbohydrate antigen 19-9; WBC: White blood cell; NE: Neutrophil count; Hgb: Hemoglobin; PLT: Platelet count; ALT: Alanine transaminase; ALB: Albumin; TBil: Total bilirubin; PT: Prothrombin time; CRE: Creatinine.

Table 2 Tumor response (n = 36), n (%)

Characteristics	RECIST
Complete response	0
Partial response	17 (47.2)
Stable disease	17 (47.2)
Progressive disease	2 (5.6)
Objective response rate, %	47.2
Disease control rate, %	94.4

RECIST: Response Evaluation Criteria in Solid Tumors.

Table 3 Summary of adverse events by severity, n (%)

Adverse event	Any grade	Grade 1-2	Grade 3	Grade 4	Treatment-related grade ≥ 3
Total	40 (100.0)	28 (70.0)	11 (27.5)	1 (2.5)	12 (30.0)
Hypoalbuminemia	39 (97.5)	39 (97.5)	0	0	0
Abdominal pain	24 (60.0)	22 (55.0)	2 (5.0)	0	2 (5.0)
ALT level elevated	19 (47.5)	19 (47.5)	0	0	0
CRE level elevated	19 (47.5)	19 (47.5)	0	0	0
Anemia	15 (37.5)	14 (35.0)	1 (2.5)	0	1 (2.5)
Hyperbilirubinemia	15 (37.5)	13 (32.5)	2 (5.0)	0	2 (5.0)
Neutropenia	14 (35.0)	13 (32.5)	1 (2.5)	0	1 (2.5)
Thrombocytopenia	14 (35.0)	13 (32.5)	1 (2.5)	0	1 (2.5)
Leukocytopenia	13 (32.5)	12 (30.0)	1 (2.5)	0	1 (2.5)
Vomiting	9 (22.5)	9 (22.5)	0	0	0
Dysuria	6 (15.0)	6 (15.0)	0	0	0
Hypertension	5 (12.5)	1 (2.5)	4 (10.0)	0	4 (10.0)
Nausea	3 (7.5)	3 (7.5)	0	0	0
Chest distress	3 (7.5)	3 (7.5)	0	0	0
Diarrhea	3 (7.5)	3 (7.5)	0	0	0
Allergy	3 (7.5)	2 (5.0)	1 (2.5)	0	1 (2.5)
Ascites	2 (5.0)	2 (5.0)	0	0	0
Constipation	2 (5.0)	2 (5.0)	0	0	0
Insomnia	2 (5.0)	2 (5.0)	0	0	0
Rash	2 (5.0)	2 (5.0)	0	0	0
Poor appetite	1 (2.5)	1 (2.5)	0	0	0
Bloating	1 (2.5)	1 (2.5)	0	0	0
Fever	1 (2.5)	1 (2.5)	0	0	0
HE	1 (2.5)	0	0	1 (2.5)	1 (2.5)

ALT: Alanine transaminase; CRE: Creatinine; HE: Hepatic encephalopathy.