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烟酸在新诊断胶质母细胞瘤的 I 期剂量递增临床试验中调节免疫反应

英文原题:Niacin Modulates Immune Responses in a Phase I Dose-Escalation Clinical Trial of Newly Diagnosed Glioblastoma.

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Niacin Modulates Immune Responses in a Phase I Dose-Escalation Clinical Trial of Newly Diagnosed Glioblastoma.

PubMed 2026/02/03(内容时间) Neurol Neuroimmunol Neuroinflamm Q1 · IF 8(JCR 2025)

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研究概要

这些数据表明,烟酸在胶质母细胞瘤患者中诱导了全身性免疫调节效应,使免疫格局向抗肿瘤表型转变,并支持进一步评估烟酸作为潜在治疗辅助手段。试验注册信息:这项正在进行的研究于 2021 年 3 月 1 日注册为 NCT04677049,首例患者于 2021 年 3 月 18 日入组。证据分类:本研究提供 IV 级证据,表明烟酸剂量递增可调节接受标准治疗的胶质母细胞瘤患者的免疫反应,标准治疗包括最大安全范围切除、同步放疗和替莫唑胺,以及辅助替莫唑胺给药。这是一项 IV 级研究,因为它是开放标签试验,无盲法或对照组。

研究思路结论见上方概要

胶质母细胞瘤是一种高度侵袭性且普遍致命的脑肿瘤,它通过形成强效的免疫抑制微环境来抵抗现有治疗和免疫疗法。本研究的目的是确定烟酸是否调节新诊断胶质母细胞瘤患者的全身免疫。

在一项首次人体I期临床试验(NCT04677049)中,我们研究了在新诊断的胶质母细胞瘤患者中,在标准治疗手术和放化疗的同时给予烟酸的免疫学效应。

烟酸治疗增加了循环记忆T细胞和NK 细胞的频率,同时减少了非经典单核细胞。此外,烟酸提高了血清中促炎细胞因子白细胞介素(IL)-12p70和粒细胞集落刺激因子的水平,并降低了生长调节α蛋白。

展开英文摘要原文

In a first-in-human phase I clinical trial (NCT04677049), we investigated the immunologic effects of niacin administration alongside standard-of-care surgery and chemoradiation in patients with newly diagnosed glioblastoma.

Niacin treatment increases the frequencies of circulating memory T cells and natural killer cells while decreasing nonclassical monocytes. Furthermore, niacin elevated serum levels of the proinflammatory cytokine interleukin (IL)-12p70 and granulocyte colony-stimulating factor and reduced growth-regulated α protein. DISCUSSION: These data demonstrate that niacin induces systemic immunomodulatory effects in patients with glioblastoma, shifting the immune landscape toward an antitumor profile and supporting further evaluation of niacin as a potential therapeutic adjunct. TRIAL REGISTRATION INFORMATION: This ongoing study was registered as NCT04677049 on March 1, 2021, with the first patient enrolled on March 18, 2021. CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that niacin dose escalation modulates immune response in patients with glioblastoma treated with standard of care, including maximal safe resection, concurrent radiation and temozolomide, and adjuvant temozolomide administration. This is a Class IV study because it is an open-label trial with no blinding or comparison group.

论文信息

作者
Poon CC、Hagen KM、Sarkar S、Mirzaei R、Silva C、Ueno A、de Robles P、Roldan-Urgoiti G
单位
Department of Clinical Neurosciences, University of Calgary, Alberta, Canada.Canada
文献类型
I 期临床试验 · II 期临床试验
期刊
Neurology(R) neuroimmunology & neuroinflammation2026 Mar
原文标识
PubMed 41632924 · DOI 10.1212/NXI.0000000000200530