Phase I clinical study of personalized peptide vaccination combined with radiotherapy for advanced hepatocellular carcinoma

Table 1 Characteristics of all the patients

Patients	Age	Sex	BCLC stage	HK	Tumor site(s)	Radiotherapy target	Dose of radiotherapy	Cycle(s) of PPV-DC-CTL
P1	66	Male	B	IIIB	Liver	Partial liver mass	PGTV 5 Gy*10f; PTV 2.5 Gy*10f	3
P2	56	Female	B	IIIB	Liver	Partial liver mass	PGTV 5 Gy*10f; PTV 2.5 Gy*10f	3
P3	54	Male	C	IVa	Liver and portal vein tumor thrombosis	Portal vein tumor thrombosis	PGTV 5 Gy*10f; PTV 2.5 Gy*10f	2
P4	37	Male	C	IVa	Bone and lung	Bone metastasis	PGTV 4 Gy*10f; PTV 3 Gy*10f	3
P5	56	Male	C	IVa	Liver and peritoneal metastases	Peritoneal metastasis	PTV 0.5 Gy BID *2f	2
P6	45	Male	B	IIIB	Liver	-	-	2
P7	43	Male	B	IIIB	Liver	Partial liver mass	PGTV 5 Gy*10f; PTV 2.5 Gy*10f	3
P8	59	Male	C	IVa	Liver and lung	Partial lung mass	PGTV 5 Gy*10f; PTV 2.5 Gy*10f	1
P9	72	Male	C	IVa	Lung	-	-	2

Table 2 Clinical outcomes of the nine patients

Patient	Change of AFP	AFP before treatment	AFP after first cycle	AFP after second cycle	AFP after third cycle	Radiological evaluation
P1	↓	168.5	118.0	29.7	27.3	PR
P2	↓	94.9	53.8	59.8	50.2	PR
P3	↓	4942.3	3297.1	3180.0	-	PR
P4	↓	1691.6	619.7	312.2	302.0	SD
P5	↓	45.7	25.9	24.1	-	SD
P6	↓	11.6	1.7	2.9	-	SD
P7	↑	1029.7	1700.0	3800.0	3818.3	PD
P8	↑	737.8	2005.6	-	-	PD
P9	↑	157.5	294.1	248.0	-	PD

AFP: Alpha-fetoprotein; PR: Partial response; SD: Stable disease; PD: Progressive disease

Table 3 Side effects of radiotherapy combined with PPV-DC-CTL immunotherapy

	Grade 1	Grade 2	Grade 3	Grade 4
Constitutional symptom
Fever	6	0	0	0
Tumor pain	0	0	0	0
Rash	2	0	0	0
Diarrhea	0	0	0	0
Respiratory
Dyspnea	0	0	0	0
Hypoxia	0	0	0	0
Neurological
CNS cerebrovascular ischemia	0	0	0	0
Blood/bone marrow
Anemia	2	0	0	0
Neutropenia	0	1	0	0
Lymphocytopenia	0	0	0	0
Thrombocytopenia	3	0	0	0
Metabolic and laboratory
AST elevation	0	0	0	0
ALT elevation	0	0	0	0
Scr elevation	0	0	0	0
BUN elevation	0	0	0	0

Table 4 Changes of lymphocytes before and after treatment

	CD3+	CD4+	CD8+	NK	B
Before treatment	54.7% ± 18.5%	32.3% ± 11.9%	15.4% ± 7.0%	16.0% ± 9.3%	8.5% ± 5.3%
After treatment	76.9% ± 16.1%a	37.9% ± 11.0%	32.0% ± 14.8%a	23.8% ± 14.8%a	2.8% ± 3.1%a

^aP < 0.05. NK: Natural killer