新型肿瘤电场治疗仪治疗复发脑胶质母细胞瘤的前瞻性、单中心、单臂探索性临床试验方案  

A new tumor electric fields treatment system for patients with relapsed glioblastoma:study protocol for a prospective, unicentre, open-label, single-arm, exploratory clinical trial

作　　者：罗承科[1] 许胜超 周单 陈迪康 肖志强[3] 陈凌 刘志雄[1] LUO Cheng-Ke;XU Sheng-Chao;ZHOU Dan;CHEN Di-Kang;XIAO Zhi-Qiang;CHEN Ling;LIU Zhi-Xiong(Department of Neurosurgery,Xiangya Hospital of Central South University,Changsha,Hunan 410008,China;Hunan An Tai Kang Cheng Biotechnology Co.,Ltd,Changsha,Hunan 410000,China;Research Center of Carcinogenesis and Targeted Therapy,Xiangya Hospital of Central South University,Changsha,Hu-nan 410008,China;Department of Neurosurgery,Chinese People's Liberation Army of China(PLA)General Hospital,Medical School of Chi-nese PLA,Institute of Neurosurgery of Chinese PLA,Beijing,100853,China)

机构地区：[1]中南大学湘雅医院神经外科,湖南长沙410008 [2]湖南安泰康成生物技术有限公司,湖南长沙410000 [3]中南大学湘雅医院癌变与靶向治疗研究中心,湖南长沙410008 [4]中国人民解放军总医院神经外科,北京100853

出　　处：《国际神经病学神经外科学杂志》2022年第1期1-7,共7页Journal of International Neurology and Neurosurgery

基　　金：国家自然科学基金(81873635,81902553,82172685);湖南省自然科学青年基金(2019JJ50942);湖南省自然科学基金(2019JJ50963)。

摘　　要：多形性胶质母细胞瘤(GBM)是原发性脑肿瘤中恶性程度最高的一种肿瘤,不但进展迅速且预后极差。肿瘤电场治疗(TTF)已被批准用于治疗GBM且具有良好的疗效。但是,尚无有关中国GBM患者采用TTF治疗的临床资料。该文报告一项复发性GMB的前瞻性、单中心、单臂探索性临床试验方案。该试验采用笔者开发的新型肿瘤电场治疗系统ASCLU-300,对参加者进行治疗。主要是评价该治疗系统的安全性和可行性。通过评估与治疗相关不良反应的患者人数,及根据进展时间(TTP)和总生存期(OS)来评价治疗反应;根据神经肿瘤治疗反应评价(RANO)标准进行评估,通过对比MRI检查确定TTP,并通过随访收集OS数据;与治疗相关的不良反应评估将基于描述性方法;通过Kaplan-Meier方法评估TTP和OS。这项初步研究将为进一步的大规模试验打下坚实基础,同时笔者希望新型肿瘤电场治疗系统能够有效治疗GBM,为中国GBM患者提供新的治疗方案。Glioblastoma multiforme(GBM)is the most malignant primary brain tumor with rapid progression and poor prognosis. Tumor treating fields(TTF)has been approved for the treatment of GBM exhibiting promising efficacy. However,there is no clinical data about the treatment of TTF in Chinese patients with GBM. Herein,we conducted a prospective,single-center,single-arm,exploratory study. The participants will receive the treatment of the ASCLU-300 system. The primary outcome measurement is the safety and feasibility. The treatment response is estimated by the number of patients who experienced a treatment-related adverse event,time to progression(TTP)and overall survival(OS). TTP is determined by contrast MRI examination according to response assessment in neuro-oncology(RANO)criteria and OS is collected duringfollow-up. Evaluation of treatment-related adverse events will be based on descriptive method. TTP and OS distributions are collected by Kaplan-Meier method and analyzed by the log-rank test. This pilot study will pave the way to further large-scale trials,and we expect the new system could treat GBM with promising efficacy and high cost-effectiveness.(Trial registration:NCT0441793;Registered 8 th Jun,2020-Retrospectively registered.)

关 键 词：电场治疗 研究方案 胶质母细胞瘤 

分 类 号：R739.41[医药卫生—肿瘤]