Intra-tumor injection of H101, a recombinant adenovirus, in combination with chemotherapy in patients with advanced cancers: A pilot phase II clinical trial

Table 1 Patients’ demographics

Characteristic
Age (yr)
Median	52
Range	18-76
Sex
Male (%)	35 (70%)
Female (%)	15 (30%)
ECOG Performance Status
Grade 0	15 (30%)
Grade 1	21 (42%)
Grade 2	14 (28%)
Pretreatment
Total	39 (78%)
Surgical	24 (48%)
Chemotherapy	37 (74%)
Radiotherapy	20 (40%)
Biotherapy	8 (16%)
Two or more treatment	31 (62%)
Tumor size (cm2)
Median	12.5
Range	1.43-360

Table 2 Response of H101 injected lesion and control lesion

Lesion	n	Median area (cm2)	Efficacy					Response rate (%)
			CR	PR	MR	SD	PD
H101 injection	46	12.5	3	11	11	13	8	30.4
Control	46	11.3	1	5	7	21	12	13.0

CR, complete regression; PR, partial regression; MR minor response; SD, stable disease; and PD, progressive disease. Re-sponse rate was calculated from cases with CR and PR over cases in each group.

Table 3 Efficacy of 46 evaluable patients treated with H101 and chemotherapy

Type of tumor	n	Response (CR + PR)
SCCHN1	15	4
Esophageal cancer	8	3
Gastric cancer	5	0/
Lung cancer	4	1
Colorectal cancer	3	1
Breast cancer	3	1
Soft tissue sarcoma	3	1
Malignant melanoma	2	1
Lymphoma	1	1
Chordoma	1	1
Ovarian cancer	1	0

¹SCCHN, squamous cell carcinoma of head and neck.

Table 4 Treatment-related toxicity

Adverse event	Grade				Total (%)
	I	II	III	IV
Fever	10	5	1	0	16 (30.2)
Injection site pain	12	2	0	0	14 (26.4)
Nausea and vomiting	13	5	0	0	18 (34.0)
Leucopenia	12	7	3	4	26 (49.1)
Liver dysfunction	2	0	0	1	3 (5.7)
Flu-like symptom	13	2	0	0	15 (28.3)
Alopecia	3	3	1	0	7 (13.2)

Table 5 Humoral immune response and plasma H101 viral genome test

	Before injection		After injection
	Negative	Positive	Negative	Positive
Ad neutralizing titer	11	3	5	9
Plasma H101 PCR	11	0	7	4