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免疫疗法治疗胶质母细胞瘤的临床试验趋势:进展与挑战观察。

Trends in Immunotherapy Clinical Trials to Treat Glioblastoma: A Look at Progress and Challenges.

机构信息

Department of Neurological Surgery, Icahn School of Medicine at Mount Sinai, New York, New York, USA.

Department of Neurological Surgery, Icahn School of Medicine at Mount Sinai, New York, New York, USA.

出版信息

World Neurosurg. 2023 Oct;178:e819-e827. doi: 10.1016/j.wneu.2023.08.020. Epub 2023 Aug 12.

Abstract

PURPOSE

We aimed to catalog past and present clinical trials on immunotherapy treatments for glioblastoma (GBM) and discover relevant trends in this field.

METHODS

Former and ongoing clinical trials involving the use of immunotherapy to treat GBM were queried in July 2022 within the clinicaltrials.gov registry (https://clinicaltrials.gov/). Pertinent trials were categorized by variables including immunotherapy classification, tumor type (newly diagnosed versus recurrent), country of origin, start date, clinical phase, study completion status, estimated subject enrollment, design, publication status, and funding source.

RESULTS

A list of 173 trials was identified in total. The number of immunotherapy clinical trials to treat GBM has increased over time. The largest proportion of trials were gene therapies (97 studies; 56.1%) and viral therapies (37 studies; 21.4%). Studies were designated as a biologic (45.1%), drug (43.9%), genetic (2.3%), or procedure (1.2%). Trials spanned 19 countries; China, the second largest contributor (5.8%) after the United States (70.0%), has increased clinical trial development in the past years. The average time to completion was 52.3 months. Trials were primarily funded by academic centers; however, one-fourth of the trials were funded by industry and 2 were funded by foundations. One-t of the trials were active and over one-third were linked to publications.

CONCLUSIONS

Our findings provide a comprehensive summary of the state of immunotherapy clinical trials for GBM, highlighting the evolving nature and growing scope of this field.

摘要

目的

我们旨在对胶质母细胞瘤(GBM)免疫治疗的既往和现有临床试验进行编目,并发现该领域的相关趋势。

方法

2022 年 7 月,在 clinicaltrials.gov 注册中心(https://clinicaltrials.gov/)中查询了涉及免疫疗法治疗 GBM 的既往和正在进行的临床试验。根据免疫疗法分类、肿瘤类型(新诊断与复发性)、来源国、开始日期、临床阶段、研究完成状态、预计入组受试者数量、设计、发表状态和资金来源等变量对相关试验进行分类。

结果

共确定了 173 项试验。治疗 GBM 的免疫疗法临床试验数量随着时间的推移而增加。最大比例的试验是基因疗法(97 项研究;56.1%)和病毒疗法(37 项研究;21.4%)。研究被指定为生物制剂(45.1%)、药物(43.9%)、遗传(2.3%)或程序(1.2%)。试验跨越 19 个国家;中国是继美国(70.0%)之后的第二大贡献者(5.8%),近年来在临床试验开发方面有所增加。平均完成时间为 52.3 个月。试验主要由学术中心资助;然而,四分之一的试验由工业界资助,2 项由基金会资助。四分之一的试验是活跃的,超过三分之一的试验与出版物有关。

结论

我们的研究结果提供了免疫疗法治疗 GBM 临床试验的全面总结,突出了该领域的发展性质和不断扩大的范围。

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