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: 目的 基于clinicaltrial平台,分析2002年至2023年肿瘤治疗性疫苗临床试验的现状及特征,探讨肿瘤治疗性疫苗目前临床转化研究中面临的问题与挑战。方法 收集clinicaltrial临床试验数据库中肿瘤治疗性疫苗的临床试验信息,从总体变化趋势、试验设计以及适应证分布等多个角度来分析肿瘤治疗性疫苗目前的临床试验现状。结果 2002年至2023年肿瘤治疗性疫苗临床试验数目总体呈态势平稳,平均每年登记注册的临床试验的项目在70项上下。纳入1563的项试验中,Ⅰ期占比62.4%(976/1563),Ⅱ期占比30.3%(474/1563),Ⅲ期占比4.4%(68/1563)。肿瘤治疗性疫苗的类型以细胞载体疫苗和多肽/蛋白疫苗为主。试验设计主要以单臂研究设计和平行对照研究设计为主。肿瘤治疗性疫苗临床试验在全球多个地区开展,分布广泛。适应证以黑色素瘤、胶质母细胞瘤、乳腺癌、前列腺癌、肺癌、胰腺癌、卵巢癌和白血病为主。结论 目前肿瘤治疗性疫苗的临床转化难度较大。但随着组学、高通量基因测序、生物算法等高通量技术的发展,相关挑战将不断被打破,肿瘤治疗性疫苗将有更好的临床转化格局。

     

    Abstract: Objective To explore the clinical landscape of therapeutic cancer vaccine and to discuss the challenges and opportunities based on the ClinicalTrial. registration platform. Methods The keyword “therapeutic cancer vaccine” was employed to retrieve relevant clinical trial information from the ClinicalTrial. registration platform. The current clinical landscape of therapeutic cancer vaccine was analyzed from the perspectives of the number of registrations, types of vaccines, indication, trial design, and geographical distribution. Results The number of clinical trials remained stable from 2002 to 2023, with an average of 70 clinical trials registered each year. Phase I accounted for 62.4% (976/1563), phase II accounted for 30.3% (474/1563) and phase III accounted for 4.4% (68/1563). The types of vaccines were mainly cell carrier vaccines and polypeptide/protein vaccines. The trial design was mainly single-arm study design and parallel control study design. The clinical trials were carried out in many regions of the world. Indications were mainly melanoma, glioblastoma, breast cancer, prostate cancer, lung cancer, pancreatic cancer, ovarian cancer and leukemia. Conclusions The research and development of therapeutic cancer vaccines is still difficult. Given the huge unmet clinical meets and the rising capacity of innovation, it is believed that therapeutic cancer vaccines contribute more to the global drug pipelines for cancer.

     

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