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

Figure 1 A 51 yr-old male patient with neck metastasis of soft palate squamous carcinoma. About 3 mo before enrollment, he had been treated with radiotherapy and Docetaxel plus DDP, but the metastatic tumor did not show any reaction to the treatment. Before the enrollment the tumor was about 2.2 × 1.5 cm² (A, arrow), then the tumor was injected with H101 5 × 10¹¹VP per day for 5 consecutive days with systemic administration of 5-Fu and DDP, after one cycle treatment the tumor regressed (B, arrow).

Figure 2 Immunohistochemical staining of Ad5 capsid from the fine-needle aspiration of the tumor tissue injected with H101 at the end of treatment cycle. The dark-brown stained granules (arrows in A) represent a positive staining indicating adenovirus replication and package in the tumor cells. However negative staining was also obtained in one of the three samples (B).