Combined transarterial chemoembolization and tislelizumab for patients with unresectable hepatocellular carcinoma

Table 1 Characteristics of the patients

Characteristics	Values
Age (years), median (P25-P75)	53 (47.5-58)
< 60, n (%)	49 (87.50)
≥ 60, n (%)	7 (12.50)
Sex, n (%)
Male	50 (89.29)
Female	6 (10.71)
Viral infection, n (%)
Hepatitis B virus	42 (75.00)
Hepatitis C virus	3 (5.36)
Hepatitis B and C viruses	11 (19.64)
Prior cancer treatment modalities, n (%)
Untreated	24 (42.86)
Surgery	6 (10.71)
Ablation therapy	3 (5.36)
TACE	23 (41.07)
Line of immunotherapy, n (%)
First-line	49 (87.5.0)
Second-line	5 (8.93)
Third-line and beyond	2 (3.57)
Immunotherapy cycles	4 (3-8.5)
≤ 4 cycles	29 (51.79)
> 4 cycles	27 (48.21)
TACE sessions, median (P25-P75)	1 (1-2)
1 time, n (%)	36 (64.29)
2 times, n (%)	13 (23.21)
3 times or more, n (%)	7 (12.50)
Immunotherapy sequence, n (%)
Before	21 (37.50)
After	35 (62.50)
Concomitant targeted/immunotherapy, n (%)
No	5 (8.93)
Yes	51 (91.07)
Targeted/immunotherapy agents, n (%)
Lenvatinib	36 (64.29)
Apatinib	3 (5.36)
Bevacizumab	3 (5.36)
Regorafenib	6 (10.71)
Sorafenib	3 (5.36)
Targeted therapy duration (months), median (P25-P75)	5 (3-9)
Tumor maximum diameter (mm), median (P25-P75)	65 (39-93.5)
Tumor distribution, n (%)
Unilateral liver	34 (60.71)
Bilateral liver	22 (39.29)
Vascular invasion, n (%)	21 (37.50)
Extrahepatic metastasis, n (%)	7 (12.50)
BCLC staging, n (%)
A	4 (7.14)
B	16 (28.57)
C	36 (64.29)
Child-Pugh score, n (%)
A	55 (98.21)
B	1 (1.79)
ECOG performance status, n (%)
0	54 (96.43)
1	2 (3.57)
AFP (ng/mL), median (P25-P75)	227.29 (38.7-9484.5)
ALT (IU/L), median (P25-P75)	38.9 (26.25-60.7)
AST (IU/L), median (P25-P75)	46 (34.25-76.2)
Total bilirubin (µmol/L), median (P25-P75)	16.4 (12.65-23.025)

TACE: Transarterial chemoembolization; BCLC: Barcelona Clinic Liver Cancer; ECOG: Eastern Cooperative Oncology Group; AFP: Α-fetoprotein; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase.

Table 2 Response evaluation

	Number of patients	ORR (95%CI)	DCR (95%CI)
Total	56	0.821 (0.717-0.923)	0.875 (0.781-0.96)
Age (years)
< 60	49	0.816 (0.704-0.929)	0.878 (0.782-0.973)
≥ 60	7	0.857 (0.508-1.207)	0.857 (0.508-1.207)
Sex
Male	50	0.8 (0.685-0.915)	0.86 (0.76-0.96)
Female	6	1 (1-1)	1 (1-1)
Viral infection
Hepatitis B virus	42	0.81 (0.686-0.933)	0.833 (0.716-0.951)
Hepatitis C virus	3	0.667 (-0.768-2.101)	1 (1-1)
Hepatitis B and C viruses	11	0.909 (0.707-1.112)	1 (1-1)
Prior cancer treatment modalities
Untreated	24	0.87 (0.721-1.018)	0.913 (0.788-1.038)
Surgery & Ablation therapy	9	0.7 (0.354-1.046)	0.8 (0.498-1.102)
TACE	23	0.87 (0.721-1.018)	0.913 (0.788-1.038)
Line of immunotherapy
First-line	49	0.857 (0.756-0.959)	0.918 (0.839-0.998)
Second-line and above	7	0.571 (0.077-1.066)	0.571 (0.077-1.066)
Immunotherapy cycles
≤ 4 cycles	29	0.862 (0.729-0.996)	0.897 (0.779-1.014)
> 4 cycles	27	0.778 (0.61-0.945)	0.852 (0.709-0.995)
Transarterial chemoembolization sessions,
1 time	36	0.889 (0.781-0.997)	0.917 (0.822-1.012)
2 times and above	20	0.7 (0.48-0.92)	0.8 (0.608-0.992)
Immunotherapy sequence
Before	21	0.714 (0.504-0.925)	0.762 (0.563-0.961)
After	35	0.886 (0.775-0.997)	0.943 (0.862-1.024)
Concomitant targeted/immunotherapy
No	5	0.8 (0.245-1.355)	0.8 (0.245-1.355)
Yes	51	0.824 (0.715-0.932)	0.882 (0.791-0.974)
Targeted/immunotherapy agents
Lenvatinib	36	0.889 (0.781-0.997)	0.917 (0.822-1.012)
Apatinib, bevacizumab, regorafenib, or sorafenib	15	0.667 (0.396-0.937)	0.8 (0.571-1.029)
Tumor distribution
Unilateral liver	34	0.941 (0.858-1.025)	0.971 (0.911-1.03)
Bilateral liver	22	0.636 (0.418-0.855)	0.727 (0.525-0.929)
Vascular invasion
Yes	21	0.8 (0.661-0.939)	0.857 (0.735-0.979)
No	35	0.857 (0.694-1.02)	0.905 (0.768-1.042)
Extrahepatic metastasis
Yes	7	0.816 (0.704-0.929)	0.878 (0.782-0.973)
No	49	0.857 (0.508-1.207)	0.857 (0.508-1.207)
BCLC staging
A or B	20	0.9 (0.756-1.044)	0.95 (0.845-1.055)
C	36	0.9 (0.756-1.044)	0.95 (0.845-1.055)

ORR: Objective response rate; DCR: Disease control rate; TACE: Transarterial chemoembolization; BCLC: Barcelona Clinic Liver Cancer.

Table 3 Adverse events

	n (%)
Elevated ALT
Grade 0-2	51 (91.07)
Grade ≥ 3	5 (8.93)
Elevated AST
Grade 0-2	50 (89.29)
Grade ≥ 3	6 (10.71)
Elevated total bilirubin
Grade 0-2	54 (96.43)
Grade ≥ 3	2 (3.57)
Rash
Grade 0-2	54 (96.43)
Grade ≥ 3	2 (3.57)
Itching
Grade 0-2	56 (100.00)
Grade ≥ 3	0
Vomiting
Grade 0-2	56 (100.00)
Grade ≥ 3	0
Diarrhea
Grade 0-2	56 (100.00)
Grade ≥ 3	0
Sensory abnormalities
Grade 0-2	56 (100.00)
Grade ≥ 3	0
Thyroiditis
Grade 0-2	56 (100.00)
Grade ≥ 3	0
Abdominal pain
Grade 0-2	56 (100.00)
Grade ≥ 3	0
Gastric ulcer
Grade 0-2	56 (100.00)
Grade ≥ 3	0
Bone marrow suppression
Grade 0-2	56 (100.00)
Grade ≥ 3	0

ALT: Alanine aminotransferase; AST: Aspartate aminotransferase.