肿瘤细胞治疗研究
英文原题：Clinical Trial Assessing the Efficacy and Safety of Dendritic Cell-Based Immunotherapy for Glioblastoma
⚠ 该试验的登记信息已有 18 个月未更新， 页面上显示的「尚未开始招募」可能已经失效。联系研究中心之前，建议先到 ClinicalTrials.gov 核对登记原文的最新状态与联系方式。
这是一项 III 期注册临床试验，评估树突状细胞治疗胶质母细胞瘤的安全性、可行性及初步疗效。当前状态：尚未开始招募。计划入组 186 例。登记号：NCT06749925。
不限性别 · ≥ 18 Years
纳入标准：成人，组织学诊断胶质母细胞瘤且已确认IDH状态；正在接受包括手术、化疗和放疗在内的标准治疗；有治疗前磁共振成像（MRI）；能够每2个月参加临床随访；入组时功能状态评分>50；肿瘤细胞可在培养中扩增。排除标准：合并其他肿瘤（基底细胞癌除外）；妊娠或哺乳；研究团队判定的显著医疗/手术状况、精神障碍，或需使用可能干扰研究程序或疫苗安全性/疗效评估的药物或治疗；HIV阳性、免疫抑制和/或既往器官移植；拒绝或无法提供知情同意（如失语患者）；入组前6个月内参加任何试验性治疗方案。
Inclusion Criteria: * Adult patients with a histological diagnosis of glioblastoma and confirmed IDH status. * Currently undergoing standard-of-care treatment, which includes surgery, chemotherapy, and radiotherapy. * Availability of pre-treatment magnetic resonance imaging (MRI). * Ability to attend clinical follow-ups every 2 months. * Functional performance score \> 50 at the time of study enrollment. * Tumor cells capable of expansion in culture. Exclusion Criteria: * Patients with any concomitant neoplasm (except basal cell carcinoma). * Pregnant or breastfeeding individuals. * Patients with significant medical or surgical conditions as determined by the study team, psychiatric disorders, or those requiring medications or treatments that could interfere with study procedures or the evaluation of the vaccine's safety and efficacy. * Patients who are HIV-positive, immunosuppressed, and/or have undergone organ transplantation. * Refusal or inability to provide consent, such as patients with aphasia. * Participation in any experimental treatment protocols within the 6 months prior to enrollment.
以上为辅助阅读译文。是否适合入组须由主治医生判断，最终以登记平台与研究者确认为准。
主要终点：Overall Survival · The primary expected outcome is overall survival, evaluated over a 2-year period. · From enrollment to the end of treatment at 2 years
次要终点：Disease Progression and Survival Metrics；Quality of life and general health assessment；Immunological Response；Safety Profile
接受树突状细胞疫苗。
接受树突状细胞疫苗联合帕博利珠单抗。
接受安慰剂，作为对照。
III期、多中心、安慰剂对照临床试验，采用序贯随机分组，旨在评估杂交树突状细胞（DC）实验性疫苗治疗胶质母细胞瘤的疗效和安全性。研究在圣保罗大学医学院临床医院（HCFMUSP）和圣保罗大学生物医学科学研究所（ICB/USP）开展，由José Alexandre Marzagão Barbuto教授牵头，神经外科、病理学、血液学等多学科研究团队参与。研究旨在确定完成手术、化疗和放疗等标准治疗的成人胶质母细胞瘤患者接受杂交DC疫苗后是否可提高总生存期。次要目标包括评估无进展生存期、生活质量、免疫反应和干预安全性。计划入组186例并随机分为三组：安慰剂对照组、DC疫苗组、DC疫苗联合帕博利珠单抗组。
This Phase III, multicenter, placebo-controlled clinical trial with sequential randomization is designed to evaluate the efficacy and safety of an experimental vaccine composed of hybrid dendritic cells (DCs) for the treatment of glioblastoma. Conducted at the Hospital das Clínicas of the University of São Paulo Medical School (HCFMUSP) and the Institute of Biomedical Sciences of the University of São Paulo (ICB/USP), the study is led by Professor José Alexandre Marzagão Barbuto. A multidisciplinary team of researchers specializing in neurosurgery, pathology, hematology, and other fields will contribute to a comprehensive approach. The trial aims to determine whether the hybrid DC vaccine can increase overall survival in adult patients with glioblastoma who have completed standard treatment, including surgery, chemotherapy, and radiotherapy. Secondary objectives include evaluating progression-free survival, quality of life, immune response, and the safety of the intervention. The study will enroll 186 patients, who will be randomized into three groups: (1) a control group receiving placebo, (2) a group receiving the DC vaccine, and (3) a group receiving the DC vaccine combined with pembrolizumab.
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