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肿瘤治疗性疫苗临床试验现状分析

Clinical Landscape of Therapeutic Cancer Vaccines: Challenges and Opportunities

    摘要
  • 摘要:
    目的 通过分析肿瘤治疗性疫苗临床试验的现状及其特征，了解现阶段肿瘤治疗性疫苗临床转化研究的总体进度及其发展趋势。
    方法 系统检索ClinicalTrial临床试验注册平台，获取2002—2023年肿瘤治疗性疫苗临床试验相关信息，包括分期、疫苗类型、研究设计及地理分布等，并进行总结分析。
    结果 共获取2002—2023年肿瘤治疗性疫苗临床试验1563项，年均登记注册约70项。其中Ⅰ期976项(62.4%，976/1563)、Ⅱ期474项(30.3%，474/1563)、Ⅲ期68项(4.4%，68/1563)、其他45项(2.9%，45/1563)。Ⅰ~Ⅲ期临床试验在全球多个地区开展，多中心临床试验482项(31.8%)、单中心临床试验1036项(68.2%)，疫苗类型以细胞载体疫苗(38.7%，588/1518)和蛋白/多肽疫苗(34.1%，518/1518)为主，研究设计主要为单臂研究(55.3%，840/1518)和随机对照研究(27.8%，422/1518)。疫苗适应证前5位依次为黑色素瘤(16.5%，251/1518)、胶质母细胞瘤(8.9%，135/1518)、乳腺癌(8.6%，130/1518)、前列腺癌(8.5%，129/1518)、肺癌(8.1%，123/1518)。
    结论 肿瘤治疗性疫苗临床试验整体发展平稳，以探索性试验为主。疫苗类型主要为细胞载体疫苗，研究设计主要为单臂研究和随机对照研究，疫苗适应证多见于黑色素瘤、胶质母细胞瘤和乳腺癌。目前该领域临床转化存在较大难度，原因可能与免疫微环境的复杂性、患者异质性及疫苗设计和制备面临的挑战等因素有关。随着蛋白组学、基因测序、生物算法等新兴技术的应用，有望突破肿瘤治疗性疫苗研究的壁垒，实现更好的临床转化格局。

     

    Abstract:
    Objective To explore the status and characteristics of clinical trials of therapeutic cancer vaccines, and provide the overall trend of clinical translational research of therapeutic cancer vaccines.
    Methods The ClinicalTrial registration platform was employed to retrieve relevant clinical trial information of therapeutic cancer vaccines from 2002 to 2023. The current clinical landscape of therapeutic cancer vaccines was analyzed from the perspectives of the number of registrations, types of vaccines, trial design, and geographical distribution.
    Results A total of 1563 clinical trials for therapeutic cancer vaccines were obtained from 2002 to 2023, with an average annual registration of approximately 70 trials. Among these, phase Ⅰ trials accounted for 976 (62.4%, 976/1563), phase Ⅱ trials for 474 (30.3%, 474/1563), phase Ⅲ trials for 68 (4.4%, 68/1563), and other types for 45 (2.9%, 45/1563). Clinical trials from phase Ⅰ to phase Ⅲ were conducted in multiple regions worldwide, with multicenter clinical trials totaling 482 (31.8%) and single-center clinical trials totaling 1036 (68.2%). The main types of vaccines were cell vector vaccines (38.7%, 588/1518) and protein/peptide vaccines (34.1%, 518/1518), with the primary research designs being single-arm studies (55.3%, 840/1518) and randomized controlled trials (27.8%, 422/1518). The top five indications for the vaccines were melanoma (16.5%, 251/1518), glioblastoma (8.9%, 135/1518), breast cancer (8.6%, 130/1518), prostate cancer (8.5%, 129/1518), and lung cancer (8.1%, 123/1518).
    Conclusions The overall development of clinical trials for therapeutic cancer vaccines has been stable and primarily focused on exploratory trials. The main types of vaccines were cell vector vaccines, and the main research designs were single-arm studies and randomized controlled trials. The vaccines were commonly indicated for melanoma, glioblastoma, and breast cancer. Currently, there are significant challenges in the clinical translation in this field, which may be due to the complexity of the immune microenvironment, patient heterogeneity, and the challenges in vaccine design and preparation. With the application of high-throughput technologies such as proteomics, genomic sequencing, and bioinformatics, it is expected that barriers in the research of therapeutic cancer vaccines would be overcome, thus leading to a better clinical translation landscape.

     

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