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

作　　者：WeiLu ShuZheng Xu-FengLi Jian-JinHuang XiaoZheng ZhenLi 

机构地区：[1]CancerCenter,SecondAffiliatedHospital,MedicalCollege,ZhejiangUniversity,Hangzhou310009,ZhejiangProvince,China [2]ZhejiangCancerHospital,Hangzhou310022,ZhejiangProvince,China

出　　处：《World Journal of Gastroenterology》2004年第24期3634-3638,共5页世界胃肠病学杂志（英文版）

基　　金：Supported by China "863" Hi-tech R&D Program,No.2002AA2Z3304

摘　　要：AIM: HI01, an EIB 55 kD gene deleted adenovirus, has been shown to possess oncolysis activity experimentally and proved to be safe in preliminary phase I study. The current study was designed to evaluate its anti-tumor activity and toxicity in combination with chemotherapy in patients with late stage cancers.METHODS: H101 5.0×10^11 virus particles were given by intra-tumor injection daily for five consecutive days at every three-week cycle, combined with routine chemotherapy,to one of the tumor lesions of 50 patients with different malignant tumors. Tumor lesions without H101 injection in the same individuals were used as controls. The efficacy and toxicity were recorded.RESULTS: Forty-six patients were evaluable with a 30.4% response rate. H101 injection in combination with chemotherapy induced three complete response (CR) and 11 partial response (PR), giving an overall response rate of 28.0% (14/50) among intention-to-treat patients. The response rate for the control lesions was 13.0%, including one case with CR and five cases with PR, which was significantly lower than that for the injected lesions (P<0.05).Main side effects were fever (30.2%) and pain at the injected sites (26.9%). Grade 1 hepatic dysfunction was found in four patients, grade 2 in one patient, and grade 4 in one patient. Hematological toxicity (grade 4) was found in four patients.CONCLUSION: Intra-tumor injection of the genetically engineered adenovirus H101 exhibits potential anti-tumor activity to refractory malignant tumors in combination with chemotherapy. Low toxicity and good tolerance of patients to H101were observed.AIM:H101,an EIB 55 kD gene deleted adenovirus,has been shown to possess oncolysis activity experimentally and proved to be safe in preliminary phase I study.The current study was designed to evaluate its anti-tumor activity and toxicity in combination with chemotherapy in patients with late stage cancers. METHODS:H101 5.0×10^(11) virus particles were given by intra-tumor injection daily for five consecutive days at every three-week cycle,combined with routine chemotherapy, to one of the tumor lesions of 50 patients with different malignant tumors.Tumor lesions without H101 injection in the same individuals were used as controls.The efficacy and toxicity were recorded. RESULTS:Forty-six patients were evaluable with a 30.4% response rate.H101 injection in combination with chemotherapy induced three complete response (CR) and 11 partial response (PR),giving an overall response rate of 28.0% (14/50) among intention-to-treat patients.The response rate for the control lesions was 13.0%,including one case with CR and five cases with PR,which was significantly lower than that for the injected lesions (P<0.05). Main side effects were fever (30.2%) and pain at the injected sites (26.9%).Grade 1 hepatic dysfunction was found in four patients,grade 2 in one patient,and grade 4 in one patient.Hematological toxicity (grade 4) was found in four patients. CONCLUSION:Intra-tumor injection of the genetically engineered adenovirus H101 exhibits potential anti-tumor activity to refractory malignant tumors in combination with chemotherapy.Low toxicity and good tolerance of patients to H101were observed.

关 键 词：肿瘤内注射剂 H101 重组细胞腺病毒 化合物 化学疗法 消化系统 老年性 肿瘤 飞行员 定向Ⅱ 临床作用 

分 类 号：R735[医药卫生—肿瘤]