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ACTR-43. OPEN-LABEL PHASE 1 CLINICAL TRIAL TESTING PERSONALIZED AND TARGETED SKULL REMODELING SURGERY TO MAXIMIZE TTFIELDS INTENSITY FOR RECURRENT GLIOBLASTOMA – INTERIM ANALYSIS AND SAFETY ASSESSMENT (OPTIMALTTF-1)

机译：ACTR-43。个性化和有针对性的颅骨重塑手术的开放式阶段1临床试验以最大程度地提高复发性胶质母细胞瘤的TTFIELS强度–中期分析和安全评估（OPTIMALTTF-1）

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BACKGROUNDWe present a pre-specified interim analysis of an ongoing open-label, phase-1 IST () testing safety/efficacy of a new rGBM treatment. The intervention combines personalized skull-remodeling (SR) surgery with TTFields and best-choice chemotherapy. SR-surgery involves minor craniectomy or burr-holes personalized to enhance TTFields intensity focally in the tumor.

机译：背景我们对正在进行的开放标签1期IST（）测试新rGBM治疗的安全性/有效性进行了预先指定的中期分析。该干预将个性化的颅骨重塑（SR）手术与TTFields和最佳选择化疗结合起来。 SR手术涉及个性化的小颅骨切除术或钻孔，以增强肿瘤中TTFields的强度。

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期刊名称 other
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Anders Korshoej; Slavka Lukacova; Jens Christian Sørensen; Frederik Lundgaard Hansen; Nikola Mikic; Axel Thielscher; Søren Ole Stigaard Cortnum; Trine Lignell Guldberg; Yasmin Ramshad-Lassen; Christian Rahbek; Kåre Eg Severinsen; Gorm von Oettingen;
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年(卷),期 -1(20),Suppl 6
年度 -1
页码 vi21
总页数 1
原文格式 PDF
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1. Safety results from a pooled analysis of randomized, controlled phase II and III clinical trials and interim data from an open-label extension trial of the interleukin-12/23 monoclonal antibody, briakinumab, in moderate to severe psoriasis [J] . LangleyR.G., PappK., GottliebA.B., Journal of the European Academy of Dermatology and Venereology: JEADV . 2013,第10期

机译：安全性来自对中度至重度牛皮癣的随机对照II期和III期临床试验的汇总分析以及白介素12/23单克隆抗体briakinumab的开放标签扩展试验的中期数据
2. Study protocol for OptimalTTF-2: enhancing Tumor Treating Fields with skull remodeling surgery for first recurrence glioblastoma: a phase 2, multi-center, randomized, prospective, interventional trial [J] . Mikic N., Poulsen F. R., Kristoffersen K. B., BMC Cancer . 2021,第1期

机译：优化术语方案：第一次复发胶质母细胞瘤的颅骨重塑手术增强肿瘤处理田间：阶段，多中心，随机，前瞻性，介入试验
3. Axitinib plus avelumab in the treatment of recurrent glioblastoma: a stratified, open-label, single-center phase 2 clinical trial (GliAvAx) [J] . Gil Awada, Laila Ben Salama, Jennifer De Cremer, Journal for ImmunoTherapy of Cancer . 2020,第2期

机译：Axitinib Plus Avelumab治疗复发性胶质细胞瘤：分层，开放标签，单中心2临床试验（Gliavax）
4. P01.029 Open-label phase 1 clinical trial testing personalized and targeted skull remodeling surgery to maximize TTFields intensity for recurrent glioblastoma - Interim analysis and safety assessment (OptimalTTF-1) [O] . A R Korshoej, S Lukacova, J H Sørensen, 2018

机译：P01.029开放标签式1期临床试验测试个性化和靶向颅骨重塑手术以最大化复发胶质母细胞瘤的TTFields强度-中期分析和安全性评估（OptimalTTF-1）
5. P01.029 Open-label phase 1 clinical trial testing personalized and targeted skull remodeling surgery to maximize TTFields intensity for recurrent glioblastoma - Interim analysis and safety assessment (OptimalTTF-1) [O] . A R Korshoej, S Lukacova, J H Sørensen, 2018

机译：P01.029开放标签阶段1临床试验个性化和有针对性的头骨重塑手术，以最大化复发胶质母细胞瘤的TTFIELDS强度 - 临时分析和安全评估（OptimalTtf-1）

ACTR-43. OPEN-LABEL PHASE 1 CLINICAL TRIAL TESTING PERSONALIZED AND TARGETED SKULL REMODELING SURGERY TO MAXIMIZE TTFIELDS INTENSITY FOR RECURRENT GLIOBLASTOMA – INTERIM ANALYSIS AND SAFETY ASSESSMENT (OPTIMALTTF-1)

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