瘤内免疫治疗临床研究组织实施推荐与建议  

Implement Recommendations for Clinical Trials of Intratumoral Immunotherapy

作　　者：单鹄声 SHAN Husheng(Department of Interventional Radiology,General Hospital of the PLA Eastern Theater,Jiangsu Nanjing 210016,China)

机构地区：[1]东部战区总医院介入治疗科,江苏南京210016

出　　处：《中国医药导刊》2023年第3期249-255,共7页Chinese Journal of Medicinal Guide

摘　　要：近年来,免疫检查点疗法(ICT)在肿瘤治疗领域取得重大突破。然而,仅有少部分患者获得客观缓解,而发生的免疫相关副反应却可能致命,费用较高、免疫耐受等问题限制了其临床应用。瘤内免疫治疗直接将免疫刺激剂注入肿瘤,通过释放肿瘤抗原,激活肿瘤特异性效应T细胞,激活/增强局部和全身免疫反应。瘤内免疫治疗应用前景广阔,但目前在国内尚未在临床广泛应用,相关临床研究较少,且缺乏相应规范。本研究团队立足于丰富的肿瘤非血管介入诊疗经验,在瘤内免疫治疗方向开展了深入探索。本研究综述瘤内免疫治疗药代动力学和药效学研究内容和方向,并总结临床研究中的要点,以期为瘤内免疫治疗临床试验提供规范统一的方法、数据收集方案和结果报告规范,为临床研究人员、制药公司、伦理委员会、独立审查委员会、患者招募员和监管机构提供指导,提高瘤内免疫治疗临床试验的质量,促进研究者之间的相互理解,方便更好地评估瘤内免疫治疗临床试验,从而获得监管机构的批准,最终提高患者生存和生活质量,降低治疗相关副反应。In recent years,immune checkpoint therapy(ICT)has made major breakthroughs in the field of cancer therapy.However,only a small number of patients achieved objective remission,but the occurrence of immune-related side effects may be fatal.The high cost and immune tolerance problems limit its clinical application.Intratumoral immunotherapy,though direct injection of immunologic stimulants into the tumor,activates tumor-specific effector T cells by releasing tumor antigens to activate or enhance local and systemic immune responses.Intratumoral immunotherapy has a broad prospect,but at present,it has not been widely used in clinical practice in China,and there are few related clinical studies and lack of corresponding norms.Based on rich experience of non-vascular intervention,the author′s team has carried out in-depth exploration in the direction of intratumoral immunotherapy.This paper reviewed the content and direction of the researches on pharmacokinetics and pharmacodynamics of intratumoral immunotherapy,and summarized the main points of clinical researches of intratumoral immunotherapy,to provide standardized and unified methods,data collection protocols and results reporting norms for clinical trials of intratumoral immunotherapy,and provide guidance to clinical researchers,pharmaceutical companies,ethics committees,independent review boards,patient recruiters,and regulatory agencies,so as to improve the quality of clinical trials of intratumoral immunotherapy,promote mutual understanding among researchers,facilitate better evaluation of clinical trials for intratumoral immunotherapy for regulatory approval,and ultimately improving patient survival and quality of life and reducing treatment-related side effects.

关 键 词：瘤内注射 瘤内免疫治疗 临床试验 药代动力学 药效动力学 疗效评价 

分 类 号：R730.5[医药卫生—肿瘤]