基因重组溶瘤腺病毒治疗恶性肿瘤临床应用中国专家共识(2022年版)  

Chinese expert consensus on clinical application of recombinant oncolytic adenovirus in the treatment of malignant tumors

作　　者：中国临床肿瘤学会免疫治疗专家委员会 上海市抗癌协会肿瘤生物治疗专业委员会 许青 王宝成 Expert Committee on Immunotherapy of Chinese Society of Clinical Oncology;Professional Committee on Cancer Biotherapy of Shanghai Anticancer Association;XU Qing;WANG Baocheng

机构地区：[1]不详

出　　处：《中国癌症杂志》2023年第5期527-550,共24页China Oncology

基　　金：上海市科学技术委员会产学研医项目(18DZ1910102);上海申康医院发展中心医企融合创新协同专项(SHDC2022CRT009)。

摘　　要：溶瘤病毒作为一种新型肿瘤免疫制剂,近年来在肿瘤基础和临床研究中不断取得突破,有望在未来肿瘤免疫治疗领域发挥重要作用。目前全球共有4种溶瘤病毒药物获批上市,其中重组人5型腺病毒注射液(H101)是中国目前唯一获得批准的溶瘤病毒药物。为进一步规范溶瘤病毒肿瘤临床研究实践,完善肿瘤免疫治疗临床应用,本共识基于《溶瘤病毒治疗恶性肿瘤临床应用上海专家共识(2021年版)》,采用循证医学方法,从聚焦国内外已获批上市的溶瘤病毒药物的适应证指导范围,围绕目前尚未获批适应证但已有较高循证医学证据的溶瘤病毒临床研究结果,展望未来溶瘤病毒药物的研究发展趋势,阐明溶瘤病毒药物(主要是基因重组溶瘤腺病毒)的具体使用方法,探讨随访与疗效评估新型模式等多个方面内容,在文献检索的基础上,进行质量等级评价、证据综合,并采用德尔菲问卷调查法,对目前基因重组溶瘤腺病毒肿瘤临床应用过程中所共同关注的应用场景、抗病毒合并用药、基因检测等具体问题和热点,通过多学科专家会议讨论、问卷调查等形式,经过4次逾12个不同城市、58家医院共计86名专家意见的调查汇总、归纳梳理和总结,依托中国临床肿瘤学会免疫治疗专家委员会及上海市抗癌协会肿瘤生物治疗专业委员会,形成了《基因重组溶瘤腺病毒治疗恶性肿瘤临床应用中国专家共识(2022年版)》,以期为未来溶瘤病毒临床和基础研究探索、肿瘤一线医务人员临床实践、各级肿瘤免疫治疗医政管理等提供证据借鉴和规范依据,并为后续的相关行业指南制定奠定基础。Treatment using oncolytic virus as a new tumor immunologic agent has made continuous breakthroughs in basic and clinical research of tumor in recent years,and it is expected to play an important role in cancer immunotherapy in the future.At present,there are 4 oncolytic viruses approved for marketing in the world,among which recombinant human type-5 adenovirus(H101)is the only oncolytic virus approved in China.To further standardize the clinical research practice of oncolytic virus in tumor and improve the clinical application of cancer immunotherapy,this consensus is established based on the“Shanghai expert consensus on clinical application of oncolytic virus in the treatment of malignant tumors(2021 edition)”and guided by evidencebased methodology,focusing on the application scope of oncolytic virus approved for marketing at home and abroad,and the clinical studies of oncolytic virus with high level of evidence but not approved at present,looking forward to the future research and development trend of oncolytic virus,clarifying the specific use method of oncolytic virus(mainly recombinant oncolytic adenovirus),and exploring the new modes of follow-up,efficacy evaluation and other aspects.On the basis of literature retrieval,quality evaluation and evidence summary were carried out,and specific issues and hot topics such as the application scope,combination with antiviral drugs,gene detection and other common concerns in the clinical application of recombinant oncolytic adenovirus in cancer were discussed and investigated through multidisciplinary expert meetings,Delphi methods and other forms.The“Chinese expert consensus on clinical application of recombinant oncolytic adenovirus in treatment for malignant tumors(2022 edition)”was completed by the investigation and summarization of the opinions of 86 experts from more than 12 different cities and 58 hospitals for 4 times,relying on the Expert Committee on Immunotherapy of China Society of Clinical Oncology and the Professional Committee on Tumor Biothera

关 键 词：溶瘤病毒 腺病毒 专家共识 恶性肿瘤 免疫治疗 生物治疗 

分 类 号：R730.51[医药卫生—肿瘤]