溶瘤病毒临床试验设计考量要点中国专家共识(2024年版)  

Chinese expert consensus on the key points of oncolytic virus clinical trial design(2024 edition)

作　　者：刘福囝[1] 王振宁[1] LIU Fu-nan;WANG Zhen-ning(Department of Surgical Oncology and General Surgery,The First Hospital of China Medical University,Shenyang 110001,China)

机构地区：[1]中国医科大学附属第一医院胃肠肿瘤外科,辽宁沈阳110001

出　　处：《中国现代普通外科进展》2025年第2期85-102,共18页Chinese Journal of Current Advances in General Surgery

摘　　要：溶瘤病毒能够选择性感染并杀伤肿瘤细胞。自2005年我国首款溶瘤病毒产品重组人5型腺病毒H101获批上市以来,全球已有4款溶瘤病毒产品相继上市,全球注册和开展的溶瘤病毒类药物的临床试验已超过200项。然而,目前溶瘤病毒产品获批的适应证较少,临床获益人群及疗效机制有待进一步探索。为优化我国溶瘤病毒产品的临床试验设计,《溶瘤病毒临床试验设计考量要点中国专家共识(2024年版)》专家组在国家药品监督管理局药品审评中心发布的《溶瘤病毒类药物临床试验设计指导原则(试行)》基础上,采用循证医学方法,从溶瘤病毒作用机制、开发适应证、临床应用方式、临床试验生物学及药效学检测等角度出发,围绕目前溶瘤病毒临床试验设计的考量要点及相关内容,开展多学科专家会议讨论及问卷调查。经过三轮意见征集、梳理总结,形成《溶瘤病毒临床试验设计考量要点中国专家共识(2024年版)》,旨在为我国溶瘤病毒产品临床试验的申办者及研究者提供参考,助力相关产品快速上市,实现肿瘤治疗新突破。Oncolytic viruses can selectively infect and kill tumor cells.Since China's first oncolytic virus product recombinant human 5 adenovirus H101 was approved for market in 2005,four oncolytic virus products have entered the market globally.More than 200 clinical trials of oncolytic virus therapies have been conducted worldwide.However,the number of globally approved indications for oncolytic virus products remains limited,and the potential patient populations and therapeutic mechanisms require further clinical investigation.To further optimize the clinical trial design of oncolytic virus products in China,this consensus was developed based on the"Guiding principles for clinical trial design of oncolytic virus drugs(trial version)"issued by the National Medical Products Administration(NMPA).Based on the medicine method,from the perspective of the mechanism of action of oncolytic virus,development indication,clinical application mode,clinical trial biology and pharmacodynamic detection,etc.,multidisciplinary expert meeting discussion and questionnaire survey were carried out based on the considerations and related contents of the current clinical trial design of oncolytic virus.After three rounds of opinion collection,combing and summarizing,the"Chinese expert consensus on the key points of oncolytic virus clinical trial design(2024 edition)"was formed,aiming to provide references for sponsors and researchers of clinical trials of oncolytic virus products in China,help related products quickly go to market,and achieve new breakthroughs in tumor treatment.

关 键 词：溶瘤病毒 临床试验设计 专家共识 

分 类 号：R730.54[医药卫生—肿瘤]