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）

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

doi:10.19401/j.cnki.1007-3639.2023.05.013

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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）

指南与共识 | 更新时间：2025-12-31

- 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
- 中国癌症杂志 2023年33卷第5期页码：527-548
- 作者机构：
- 作者简介：
- 基金信息：
  
  上海市科学技术委员会产学研医项目(18DZ1910102);上海申康医院发展集团医企融合创新合作专项(SHDC2022CRT009)
- DOI：10.19401/j.cnki.1007-3639.2023.05.013
  中图分类号： R730.51
- 收稿：2023-01-12，
  
  修回：2023-02-25，
  
  纸质出版：2023-05-30
- 稿件说明：
移动端阅览
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. 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）[J]. 中国癌症杂志, 2023,33(5):527-548.

Expert Committee on Immunotherapy of Chinese Society of Clinical Oncology, Professional Committee on Cancer Biotherapy of Shanghai Anticancer Association. Chinese expert consensus on clinical application of recombinant oncolytic adenovirus in the treatment of malignant tumors[J]. China Oncology, 2023, 33(5): 527-548.
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. 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）[J]. 中国癌症杂志, 2023,33(5):527-548. DOI： 10.19401/j.cnki.1007-3639.2023.05.013.

Expert Committee on Immunotherapy of Chinese Society of Clinical Oncology, Professional Committee on Cancer Biotherapy of Shanghai Anticancer Association. Chinese expert consensus on clinical application of recombinant oncolytic adenovirus in the treatment of malignant tumors[J]. China Oncology, 2023, 33(5): 527-548. DOI： 10.19401/j.cnki.1007-3639.2023.05.013.

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。

Abstract

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 evidence-based 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 Biotherapy of Shanghai Anti-cancer Association

with a view to providing evidence reference and normative basis for future clinical and basic research exploration of oncolytic viruses

clinical practice of frontline medical personnel in cancer treatment

medical administration management at all levels for tumor immunotherapy

and laying a foundation for subsequent development of relevant industry guidelines.

关键词

Keywords

references

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