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卵巢癌治疗性疫苗的临床现状:现状、挑战与未来方向

英文原题:Clinical landscape of therapeutic vaccines for ovarian cancer: current status, challenges, and future directions.

PubMed 2026/09/10(内容时间) J Ovarian Res Q1 · IF 5.3(JCR 2025)

研究概要

过去三十年间,卵巢癌治疗性疫苗的开发取得了持续进展,但总体上仍处于早期探索阶段。尽管多种疫苗平台和联合免疫治疗策略展现出巨大的转化潜力,但确证性证据仍然有限。未来应优先开展生物标志物指导的患者筛选、个体化疫苗开发、标准化免疫监测、具有临床意义的终点指标以及大规模多中心随机II/III期临床试验,以促进疫苗诱导的免疫反应转化为切实的临床获益。观察到的免疫反应报告异质性进一步凸显了在未来疫苗试验中建立预设的、统一的、疫苗特异性免疫监测框架的必要性。

研究思路结论见上方概要

治疗性癌症疫苗通过激发肿瘤特异性免疫应答和建立长期免疫记忆,已成为卵巢癌一种有前景的免疫治疗策略。尽管经过数十年的临床研究,卵巢癌疫苗的整体研发现状、转化特征及研究趋势仍未被充分了解。

从ClinicalTrials.gov数据库检索了与卵巢癌疫苗相关的临床试验。共纳入1996年至2026年6月期间注册的136项独特研究。提取了关于研究阶段、招募状态、入组规模、地理分布、资金来源、疫苗平台、联合策略、临床应用背景和终点选择的信息,并进行了描述性分析。进一步可视化了疫苗平台、联合策略、临床阶段和终点类别之间的关系。免疫监测结局进一步根据报告特异性、检测方法类别和生物学领域进行了编码。

共识别出136项临床研究,涉及4,180名参与者。大多数研究为早期试验,包括I期(48.53%)、II期(23.53%)和I/II期(21.32%),而仅发现2项III期研究。已完成的研究占55.88%,而仅22.79%公开张贴了结果。美国主导了研究格局,参与了105项研究。主要疫苗平台包括肽/抗原疫苗、树突状细胞疫苗、全肿瘤细胞或裂解物疫苗、DNA/RNA疫苗以及病毒/载体疫苗。当前发展趋势表明,正从单一疫苗方法向涉及免疫检查点抑制剂、化疗和免疫佐剂的联合策略转变。大多数研究聚焦于晚期、转移性或复发性卵巢癌。安全性/毒性和免疫原性是最常用的终点,而无进展生存期、总生存期、生活质量和基于生物标志物的结局相对代表性不足。92项试验(67.65%)报告了免疫监测或免疫应答结局,但仅58项试验(42.65%)指定了检测方法;34项试验(25.00%)描述了免疫领域但未指明检测方法。

展开英文摘要原文

BACKGROUND: Therapeutic cancer vaccines have emerged as a promising immunotherapeutic strategy for ovarian cancer by stimulating tumor-specific immune responses and establishing long-term immune memory. Despite decades of clinical investigation, the overall development landscape, translatform characteristics, and research trends of ovarian cancer vaccines remain incompletely understood. METHODS: Clinical trials related to ovarian cancer vaccines were retrieved from the ClinicalTrials.gov database. A total of 136 unique studies registered between 1996 and June 2026 were included. Information regarding study phase, recruitment status, enrollment size, geographic distribution, funding source, vaccine platform, combination strategy, clinical application context, and endpoint selection was extracted and descriptively analyzed. Relationships among vaccine platforms, combination strategies, clinical phases, and endpoint categories were further visualized. Immune monitoring outcomes were further coded according to reporting specificity, assay-method class, and biological domain. RESULTS: A total of 136 clinical studies involving 4,180 participants were identified. Most studies were early-phase trials, including Phase I (48.53%), Phase II (23.53%), and Phase I/II (21.32%), whereas only 2 Phase III studies were found. Completed studies accounted for 55.88%, while only 22.79% had publicly posted results. The United States dominated the research landscape, participating in 105 studies. Major vaccine platforms included peptide/antigen vaccines, dendritic-cell vaccines, whole tumor cell or lysate vaccines, DNA/RNA vaccines, and viral/vector vaccines. Current development trends indicate a transition from single-vaccine approaches toward combination strategies involving immune checkpoint inhibitors, chemotherapy, and immune adjuvants. Most studies focused on advanced, metastatic, or recurrent ovarian cancer. Safety/toxicity and immunogenicity were the most frequently used endpoints, whereas progression-free survival, overall survival, quality of life, and biomarker-based outcomes were comparatively underrepresented. Immune monitoring or immune-response outcomes were reported in 92 trials (67.65%), but only 58 trials (42.65%) specified an assay method; 34 trials (25.00%) described an immune domain without a named assay. CONCLUSIONS: Therapeutic vaccine development for ovarian cancer has shown sustained progress over the past three decades but remains largely in an early exploratory stage. Although diverse vaccine platforms and combination immunotherapy strategies demonstrate substantial translational potential, confirmatory evidence remains limited. Future efforts should prioritize biomarker-guided patient selection, personalized vaccine development, standardized immune monitoring, clinically meaningful endpoints, and large-scale multicenter randomized Phase II/III trials to facilitate the translation of vaccine-induced immune responses into tangible clinical benefits. The observed heterogeneity in immune-response reporting further highlights the need for prespecified, harmonized, and vaccine-specific immune monitoring frameworks in future vaccine trials.

论文信息

作者
Shan Y、Wang Q、Wan W、Zhang Y、Chu Y
第一作者单位
Department of Obstetrics and Gynecology, The Affiliated Hospital of Qingdao University, NO.16 Jiangsu Road, Qingdao, 266000, China.China
通讯作者单位
Department of Obstetrics and Gynecology, The Affiliated Hospital of Qingdao University, NO.16 Jiangsu Road, Qingdao, 266000, China. chuyijing@qdu.edu.cn.China
文献类型
综述
期刊
Journal of ovarian research2026 Sep 10
原文标识
PubMed 42778941 · DOI 10.1186/s13048-026-02253-0