Efficacy and safety of transarterial chemoembolization with chemotherapy, PD-1/PD-L1 inhibitors, and tyrosine kinase inhibitors in unresectable intrahepatic cholangiocarcinoma

Table 1 Comparison of baseline characteristics between the two groups, n (%)

Baseline data	Experimental group (n = 41)	Control group (n = 42)	P value
Sex
Male	20 (48.8)	27 (64.3)	0.154
Female	21 (51.2)	15 (35.7)
Age
> 60	17 (41.5)	23 (54.8)	0.225
≤ 60	24 (58.5)	19 (45.2)
ECOG PS score
0	24 (58.5)	24 (57.1)	0.898
1	17 (41.5)	18 (42.9)
HBV infection
No	14 (34.1)	12 (28.6)	0.584
Yes	27 (65.9)	30 (71.4)
Cirrhosis
No	14 (34.1)	9 (21.4)	0.196
Yes	27 (65.9)	33 (78.6)
Child-Pugh
A	17 (41.5)	18 (42.9)	0.898
B	24 (58.5)	24 (57.1)
AFP (ng/mL)
< 400	34 (82.9)	30 (71.4)	0.213
≥ 400	7 (17.1)	12 (28.6)
CA19-9 (U/mL)
> 1000	7 (17.1)	10 (23.8)	0.447
≤ 1000	34 (82.9)	32 (76.2)
Max tumor size (mm)
> 50	20 (48.8)	24 (57.1)	0.445
≤ 50	21 (51.2)	18 (42.9)
Tumor number
One	7 (17.1)	6 (14.3)	0.727
More than one	34 (82.9)	36 (85.7)
Large vessel invasion
No	25 (61.0)	32 (76.2)	0.135
Yes	16 (39.0)	10 (23.8)
Extrahepatic metastasis
No	25 (61.0)	21 (50.0)	0.315
Yes	16 (39.0)	21 (50.0)
TKIs
Lenvatinib	26 (63.4)	24 (57.1)	0.121
Anlotinib	11 (26.8)	7 (16.7)
Sofantinib	4 (9.8)	11 (26.2)
PD1/PD-L1 inhibitors
Camrelizumab	19 (46.3)	21 (50.0)	0.815
Toripalimab	14 (34.2)	15 (35.7)
Pembrolizumab	8 (19.5)	6 (14.3)

ECOG PS: Eastern Cooperative Oncology Group performance status; HBV: Hepatitis B virus; AFP: Alpha fetoprotein; CA19-9: Carbohydrate antigen 19-9; TKIs: Tyrosine kinase inhibitors; PD-1: Programmed death 1; PD-L1: Programmed cell death ligand 1.

Table 2 Comparison of short-term efficacy between the two groups, n (%)

Efficacy evaluation	Experimental group (n = 41)	Control group (n = 42)	P value
Complete response	2 (4.9)	0
Partial response	14 (34.1)	8 (19.0)
Stable disease	15 (36.6)	14 (33.3)
Progressive disease	10 (24.4)	20 (47.6)
ORR	16 (39.0)	8 (19.0)	0.045
DCR	31 (75.6)	22 (52.4)	0.028

ORR: Objective response rate; DCR: Disease control rate.

Table 3 Comparison of adverse event rates between the two groups, n (%)

Treatment-related adverse events	Experimental group (n = 41)	Control group (n = 42)	P value
Nausea and vomiting	20 (48.8)	14 (33.3)	0.152
Fever	35 (85.4)	5 (11.9)	< 0.001a
Pain	24 (58.5)	4 (9.5)	< 0.001a
Weakness	13 (31.7)	18 (42.9)	0.294
Diarrhea	9 (22.0)	8 (19.0)	0.743
Constipation	17 (41.5)	19 (45.2)	0.729
Trachyphonia	4 (9.8)	2 (4.8)	0.326
Gingival hemorrhage	7 (17.1)	3 (7.1)	0.146
Hypertension	5 (12.2)	12 (28.6)	0.065
Hand-foot syndrome	15 (36.6)	17 (40.5)	0.716
Hypothyroidism	8 (19.5)	7 (16.7)	0.736
Rash	6 (14.6)	9 (21.4)	0.421
Proteinuria	7 (17.1)	8 (19.0)	0.815

^aP < 0.001.

The experimental group received transarterial chemoembolization combined with chemotherapy, tyrosine kinase inhibitors, and programmed death 1/programmed cell death ligand 1 inhibitors. The control group received chemotherapy, tyrosine kinase inhibitors, and programmed death 1/programmed cell death ligand 1 inhibitors without transarterial chemoembolization. Adverse events were graded according to the Common Terminology Criteria for Adverse Events version 5.0.