Department of Oncology, University College London Hospitals, 250 Euston Road, London, NW1 2PQ, UK.
Oncology Clinical Trials Office (OCTO), Department of Oncology, The University of Oxford, Old Road Campus Research Building, Oxford, OX3 7DQ, UK.
BMC Cancer. 2020 Mar 12;20(1):198. doi: 10.1186/s12885-020-6624-y.
Median survival for patients with glioblastoma is less than a year. Standard treatment consists of surgical debulking if feasible followed by temozolomide chemo-radiotherapy. The immune checkpoint inhibitor ipilimumab targets cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) and has shown clinical efficacy in preclinical models of glioblastoma. The aim of this study is to explore the addition of ipilimumab to standard therapy in patients with glioblastoma.
METHODS/DESIGN: Ipi-Glio is a phase II, open label, randomised study of ipilimumab with temozolomide (Arm A) versus temozolomide alone (Arm B) after surgery and chemoradiotherapy in patients with recently diagnosed glioblastoma. Planned accrual is 120 patients (Arm A: 80, Arm B: 40). Endpoints include overall survival, 18-month survival, 5-year survival, and adverse events. The trial is currently recruiting in seven centres in the United Kingdom.
ISRCTN84434175. Registered 12 November 2018.
胶质母细胞瘤患者的中位生存期不足一年。标准治疗包括如果可行则进行手术切除，然后进行替莫唑胺化疗和放疗。免疫检查点抑制剂伊匹单抗靶向细胞毒性 T 淋巴细胞相关蛋白 4（CTLA-4），并已在胶质母细胞瘤的临床前模型中显示出临床疗效。本研究旨在探讨在胶质母细胞瘤患者中添加伊匹单抗联合标准治疗的效果。
方法/设计：Ipi-Glio 是一项 II 期、开放标签、随机研究，比较了伊匹单抗联合替莫唑胺（A 组）与替莫唑胺单药（B 组）在手术和放化疗后用于新诊断的胶质母细胞瘤患者的效果。计划入组 120 例患者（A 组：80 例，B 组：40 例）。主要终点包括总生存期、18 个月生存率、5 年生存率和不良事件。该试验目前正在英国的 7 个中心招募患者。
ISRCTN84434175。注册于 2018 年 11 月 12 日。
