Phase Ⅱ clinical study of intratumoral H101,an E1B deleted adenovirus,in patients with cancer / 中国癌症杂志

ABSTRACT

Purpose:To evaluate the efficacy and toxicity o f intratumoral H101, an E1B deleted oncolytic adenovires. Methods:A total of 53 patients with malignant tumors from multiple centers were treated with H101, 5?10 11 viral particle (VP) per day for 5 consecutive days ever y three weeks. The efficacy and toxicity were evaluated. Results:Among 49 evaluable cases, complete response 2, partial response 9, minimal respo nse 8, stable disease 19, progressive disease 11, overall response rate was 22.4 %. In the 56 ITT population the response rate was 19.6%, including 2 CR and 9 PR . The rate of clinical benefit response (CR+PR+MR+SD) was 77.6% (38/49). Main si de effects were injection site pain (57.4%) and fever (35.2%). No serious advers e events developed. Conclusions:The study showed that genetical ly E1B-deleted adenovirus (H101) showed some efficacy in some refractory malign ant tumors, and was well tolerated.