Efficacy of Invariant Natural Killer T Cell Infusion Plus Transarterial Embolization vs Transarterial Embolization Alone for Hepatocellular Carcinoma Patients: A Phase 2 Randomized Clinical Trial

Figures & data

Figure 1 Patient Flow Diagram.

Table 1 Patient Demographic and Disease Characteristics

Variable	TAE-iNKT (N = 27)	TAE (N=27)
Median size of HCC(IQR), mm	64.78 (35.95–107.36)	68.90 (42.20–103.20)
Median age (IQR), year	60 (51–69)	59 (54–63)
Sex, N (%)
Male	23 (85)	24 (89)
Female	4 (15)	3 (11)
Cause of hepatocellular carcinoma, N (%)
Hepatitis B	23 (85)	21 (78)^a
Hepatitis C	2 (7)	4 (15)
Nonviral	2 (7)	3 (11)
ECOG performance status score, N (%)
0	23 (85)	21 (78)
1	4 (15)	6 (22)
Child-Pugh classification, N/total (%)
A	21/27 (78)	24/27 (89)
B	6/27 (22)	3/27 (11)
Barcelona Clinic liver cancer stage, N (%)
B	12 (44)	12 (44)
C	15 (56)	15 (56)
Alpha-fetoprotein >400 ng per milliliter, N (%)	8 (30)	5 (19)
Presence of macrovascular invasion, extrahepatic spread, or both, N (%)
Macrovascular invasion	10 (37)	13 (48)
Extrahepatic spread	11 (41)	4 (15)
Varices, N (%)
Present at baseline	16 (59)	23 (85)
Treated at baseline	1 (4)	6 (22)
Cirrhosis, N (%)
Yes	19 (70)	17 (63)
No	8 (30)	10 (37)
History of treatment
TACE (≥2 consecutive procedures), N (%)	27 (100)	27 (100)
TACE times	2~12	2~6
Systemic treatment, N (%)	2 (7)	1 (4)
Radiofrequency ablation, N (%)	9 (33)	12 (44)
Radiotherapy, N (%)	2 (7)	0 (0)
Resection, N (%)	7 (26)	1 (4)
Argon-helium knife, N (%)	2 (7)	1 (4)

Notes: ^aOne patient in the TAE group was co-infected with HBV and HCV.

Abbreviations: TACE, transarterial chemoembolization; TAE, Transarterial embolization; ECOG, Eastern Cooperative Oncology Group.

Figure 2 Kaplan-Meier Plot in the Modified Intention-to-Treat Population. (A) Progression-free survival since randomization. (B) Time from randomization to quality of life deterioration.

Figure 3 Duration of Response and Quantification of Lymphocytes. (A) Duration of response among responders. (B) Quantification of lymphocytes (ns, p>0.05; **p<0.01).

Table 2 Adverse Events

Adverse Event	Any Grade (%)	≥Grade 3 (%)
TAE-iNKT
Chill	0	0
Fatigue	3 (11)	0
Fever	3 (11)	0
Injection site reaction	0	0
Callosity	4 (15)	0
Activation time of partial prothrombin	0	0
Alanine aminotransferase increase	1 (4)	0
Aspartate aminotransferase increase	4 (15)	0
Blood bilirubin increase	3 (11)	0
Alkaline phosphatase increase	1 (4)	0
Glutamyl transpeptidase increase	6 (22)	1 (4)
Hypercholesterolemia	1 (4)	0
TAE
Chill	0	0
Fatigue	5 (19)	0
Fever	5 (19)	0
Injection site reaction	0	0
Callosity	0	0
Activation time of partial prothrombin	0	0
Alanine aminotransferase increase	8 (30)	2 (7)
Aspartate aminotransferase increase	5 (19)	0
Blood bilirubin increase	6 (22)	2 (7)
Alkaline phosphatase increase	2 (7)	0
Glutamyl transpeptidase increase	6 (22)	1 (4)
Hypercholesterolemia	1 (4)	0