Long-term results of a phase II clinical trial of superantigen therapy with staphylococcal enterotoxin C after microwave ablation in hepatocellular carcinoma

Figures & data

Table I.  Patient characteristics and tumour profile.

	Total			Subgroup one			Subgroup two
	SEC	Control	p	SEC	Control	p	SEC	Control	p
Total patients	45	215		26	131		19	84
Gender
Male	41	188	0.596	25	115	0.215	16	73	0.826
Female	4	27		1	16		3	11
Age(years)
Range	30–74	28–81	0.438	30–74	29–80	0.128	42–71	28–81	0.4
Mean ± SD	55.8 ± 9.8	57.3 ± 11.0		53.5 ± 10.2	57.2 ± 11.3		59.4 ± 8.1	57.1 ± 11.2
Child stratification
Class A	18	97	0.622	8	66	0.076	10	31	0.426
Class B	26	109		18	60		8	49
Class C	1	9		0	5		1	4
Tumour characteristics
Total tumours	66	294		39	182		27	112
Number of tumours
1	31	151	0.126	17	92	0.632	14	59	0.06
2	7	49		5	27		2	22
3	7	15		4	12		3	3
Size
Range	16–60	11–60	0.455	15–30	11–30	0.588	31–60	31–60	0.208
Median	27	29		22.5	22.5		36	36
Mean ± SD	30.2 ± 10.8	30.4 ± 9.4		23.2 ± 4.5	22.5 ± 4.8		40.2 ± 8.6	37.9 ± 6.5
Preablation treatment
Surgery	10	81	0.106	6	55	0.31	4	26	0.315
TACE	8	40		5	19		3	21
Surgery and TACE	0	4		0	1		0	3
None	27	90		15	56		12	34

TACE, transarterial chemoembolisation.

Figure 1. Estimated survival rates for SEC group and control group (0.032).

Figure 2. Survival rates of patients with single tumour or multifocal tumours (0.257).

Figure 3. Survival rates of SEC group and control group in subgroup of small tumours (0.153).

Figure 4. Disease-free survival rates of SEC group and control group in subgroup of large tumours (0.032).