肿瘤细胞治疗研究
英文原题：Adjuvant Dendritic Cell-immunotherapy Plus Temozolomide in Glioblastoma Patients
这是一项 I/II 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：进行中（不再招募）。计划入组 20 例。试验地点：欧洲 · 埃德海姆（共 1 个中心）。登记号：NCT02649582。
不限性别 · ≥ 18 Years
纳入标准：新诊断、组织学证实的胶质母细胞瘤（WHO IV级）；年龄≥18岁；接受全切或次全切除：全切指神经外科医生判断肉眼完全切除且术后（≤72小时）脑MRI无残留强化肿块；次全切指神经外科医生判断肉眼完全切除，但术后（≤72小时）脑MRI残留强化体积≤2 cm³；签署知情同意书；研究者判断愿意且能够遵守方案；预计于手术切除后≥28天且≤49天开始放化疗；适合接受白细胞单采、放化疗、化疗及免疫治疗；白细胞单采前≤1周未接受皮质类固醇治疗；WHO体能状态≤2；研究者估计预期寿命≥3个月。排除标准：其他恶性肿瘤史（充分控制的皮肤基底细胞癌、皮肤鳞状细胞癌、宫颈原位癌除外，或研究者说明可接受者除外）；既往放疗或化疗；既往存在替莫唑胺治疗禁忌证；既往存在增强脑MRI禁忌证；妊娠或哺乳；有记录的免疫缺陷或全身免疫抑制治疗；HIV、HBV、HCV或梅毒病毒血清学阳性；任何身体或心理状况（或临床/专项检查提示的合理怀疑）禁忌使用疫苗、可能降低依从性或增加治疗并发症风险。
Inclusion Criteria: * Newly diagnosed, histologically verified glioblastoma (WHO grade IV) * Aged ≥ 18 years * Total or subtotal resection: * Total resection: macroscopic complete resection as assessed by the neurosurgeon and absence of any residual contrast-enhancing mass on post-operative (≤ 72h) brain MRI * Subtotal resection: macroscopic complete resection as assessed by the neurosurgeon, but with residual contrast-enhancement ≤ 2 cm³ on post-operative (≤ 72h) brain MRI * Signed informed consent * Willing and able to comply with the protocol as judged by the Investigator * Estimated to start with chemoradiation ≥ 28 days and ≤ 49 days following surgical resection * Fit to undergo: leukapheresis, chemoradiation, chemotherapy and immunotherapy * No corticosteroid treatment ≤ 1 week before apheresis * WHO performance status ≤ 2 * Life expectancy ≥ 3 months as estimated by the Investigator Exclusion Criteria: * History of another malignancy, except for adequately controlled basal cell skin carcinoma, squamous skin carcinoma, or carcinoma in situ of the uterine cervix or unless the investigator rationalizes otherwise * Prior radiation or chemotherapy * Any pre-existing contraindication for temozolomide treatment * Any pre-existing contraindication for contrast-enhanced brain MRI * Pregnant or breast-feeding * Documented immune deficiency or systemic immune-suppressive treatment * Known positive viral serology for HIV, HBV, HCV, or syphilis * Any other condition, either physical or psychological, or reasonable suspicion thereof on clinical or special investigation, which contraindicates the use of the vaccine, or may negatively affect patient compliance, or may place the patient at higher risk of potential treatment complications
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 · Patients will be followed for survival, from apheresis (\~ diagnosis), for which the accurate date and reason of death (cancer-related or non-related) will be recorded for every patient. · Through study completion with follow-up until 90 days after final DC vaccine administration or 24 months after apheresis, whichever occurs later
次要终点：Number of glioblastoma patients post surgical resection with feasible and safe DC vaccine production；Feasibility of DC vaccine administration to glioblastoma patients combined with chemotherapy；Number of participants with adverse events as a measure of safety and tolerability；Immunological responses to the DC vaccine；Objective clinical responses by tumor evaluation (clinical efficacy)
树突状细胞疫苗联合替莫唑胺化疗。
本I/II期试验的主要目标是在新诊断胶质母细胞瘤患者中，评估在（次）全切除及替莫唑胺为基础的放化疗后，将自体Wilms肿瘤1（WT1）信使RNA（mRNA）负载树突状细胞（DC）疫苗加入辅助替莫唑胺维持治疗时的总生存期和无进展生存期。
In this phase I/II trial, the primary objective is to determine overall and progression-free survival of patients with newly diagnosed glioblastoma when autologous Wilms' tumor 1 (WT1) messenger (m)RNA-loaded dendritic cell (DC) vaccination is added to adjuvant temozolomide maintenance treatment following (sub)total resection and temozolomide-based chemoradiation.
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