随着精准医疗的快速发展，细胞外囊泡在肿瘤等疾病的诊断和转化应用中展现出巨大潜力。“载药囊泡化肿瘤靶向治 疗术”是中国原创的新型肿瘤免疫治疗技术，其以肿瘤细胞来源的微囊泡作为载体，包裹或负载临床常用小分子化疗药物，通过 药物靶向递送、趋化和激活中性粒细胞、逆转巨噬细胞极化表型及促进肿瘤抗原提呈等多重作用机制实现对肿瘤细胞的有效杀 伤。历经十余年的抗肿瘤机制探究、临床前评估及临床试验，该技术已成功完成临床转化，获批临床应用。为进一步推动“载药 囊泡化肿瘤靶向治疗术”在临床的规范和科学应用，中国免疫学会肿瘤免疫与生物治疗专业委员会和中国抗癌协会肿瘤生物治 疗专业委员会联合组织细胞外囊泡及肿瘤免疫治疗领域的技术和临床专家，经过多次商讨与修订，最终撰写了《“载药囊泡化肿 瘤靶向治疗术”临床应用专家共识》。本共识就“载药囊泡化肿瘤靶向治疗术”在肿瘤治疗领域的研究和应用进行了介绍，并对该 技术面临的挑战及未来发展方向进行了展望，旨在为其临床合理使用提供建议及参考。

With the rapid development of precision medicine, extracellular vesicles (EVs) have shown tremendous potential in the diagnosis and therapeutic applications of diseases such as tumors. Drug-Loaded Microparticles Immunotherapy is an innovative cancer immunotherapy technology originating in China. It utilizes tumor-derived microparticles as carriers, encapsulating or loading commonly used clinical small molecule chemotherapeutic drugs. This approach achieves effective tumor destruction through mechanisms such as targeted drug delivery, activation of neutrophils, reversal of macrophages polarization, and enhancement of tumor antigen presentation. Over more than a decade of research into anti-tumor mechanisms, preclinical assessments, and clinical trials, this technology has successfully transitioned to clinical application and received clinical approval. To further advance the standardized and scientific application of Drug-Loaded Microparticles Immunotherapy, Committee for Tumor Immunology & Biotherapy of Chinese Society for Immunology and the Society of Cancer Biotherapy of China Anti-Cancer Association jointly organized technical and clinical experts in the fields of extracellular vesicles and tumor immunotherapy. After multiple rounds of discussions and revisions, they collaboratively drafted the“ Expert Consensus on Clinical Application of Drug-Loaded Microparticles Immunotherapy”. This consensus introduces the research and practical application of the therapy in cancer treatment, addresses existing challenges, and outlines future development directions. Its primary goal is to offer guidance and insights for the optimal clinical use of this innovative therapeutic approach.

国家重点研发计划（No. 2022YFA1206000）；国家重点研 发计划“政府间国际科技创新合作”项目（No. 2022YFE0141000）