Chinese expert consensus on the key points of oncolytic virus clinical trial design(2024 edition)
10.3969/j.issn.1009-9905.2025.02.001
- VernacularTitle:溶瘤病毒临床试验设计考量要点中国专家共识(2024年版)
- Author:
Fu-nan LIU
1
;
Zhen-ning WANG
1
Author Information
1. 中国医科大学附属第一医院 胃肠肿瘤外科(辽宁 沈阳 110001)
- Publication Type:Journal Article
- Keywords:
Oncolytic Virus;
Clinical trial design;
Expert consensus
- From:
Chinese Journal of Current Advances in General Surgery
2025;28(2):85-102
- CountryChina
- Language:Chinese
-
Abstract:
Oncolytic viruses can selectively infect and kill tumor cells.Since China's first oncolytic virus product re-combinant 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 ques-tionnaire 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 re-searchers of clinical trials of oncolytic virus products in China,help related products quickly go to market,and achieve new breakthroughs in tumor treatment.
