Concurrent Apatinib and Brain Radiotherapy in Patients With Brain Metastases From Driver Mutation-negative Non small-cell Lung Cancer: Study Protocol for an Open-label Randomized Controlled Trial
Concurrent Apatinib and Brain Radiotherapy in Patients With Brain Metastases From Driver Mutation-negative Non small-cell Lung Cancer: Study Protocol for an Open-label Randomized Controlled Trial
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DOI：
10.1016/j.cllc.2020.10.007
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发表时间：
2021-03-19
影响因子：
3.6
通讯作者：
Han, Guang
中科院分区：
文献类型：
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作者：
Ma, Jia;Pi, Guoliang;Han, Guang
脑放射治疗（BR）是治疗非小细胞肺癌（NSCLC）多发性脑转移瘤（BM）的公认方法。然而，这些患者的预后仍然很差。阿帕替尼是一种靶向血管内皮生长因子受体2的抗血管生成药物，在多种实体瘤中显示出优异的疗效。第二阶段（WWW。ClinicalTrials.gov 标识符：VEGFR-2 NCT 03801200）随机试验，旨在评价这种联合治疗模式在驱动突变阴性NSCLC BM患者中的疗效和安全性。这是一项多中心、开放标签、随机对照临床试验。共90例合格患者将以1：1的比例分配至实验组（阿帕替尼和BR联合治疗）或对照组（BR单药治疗）。主要终点是颅内无进展生存期。次要终点包括使用标准化测量的颅内客观缓解率、颅内疾病控制率、颅内疾病进展时间、总生存期和瘤周脑水肿发生率。还将评估生活质量和不良事件。将在入组前（基线）沿着放疗后4周和12周进行评估，之后每12周一次，最长24个月。总之，本试验的目的是证明BR和阿帕替尼联合治疗驱动突变阴性NSCLC伴多种BM患者的临床疗效和安全性，以努力扩大该预后不良人群的管理选择。
Brain radiotherapy (BR) is a well-recognized approach for multiple brain metastases (BMs) from non small-cell lung cancer (NSCLC). However, the prognosis for these patients remains poor. Apatinib, an antiangiogenic agent targeting vascular endothelial growth factor receptor-2, has shown excellent efficacy in multiple solid tumors. This phase II (WWW. ClinicalTrials.gov Identifier: VEGFR-2 NCT03801200) randomized trial aims to evaluate the efficacy and safety of this combined modality paradigm in patients with BMs from driver mutation-negative NSCLC. This is a multicenter, open-label, randomized controlled clinical trial. A total of 90 eligible patients will be allocated in a 1:1 ratio, to either the experimental group (concurrent apatinib and BR) or the control group (BR alone). The primary endpoint is intracranial progression-free survival. The secondary endpoints include intracranial objective response rate, intracranial disease control rate, intracranial time to progression, overall survival, and occurrence of peritumoral brain edema using standardized measurement. Quality of life and adverse events will also be evaluated. Assessments will be carried out before enrollment (baseline) along with 4 and 12 weeks after radiotherapy, followed by every 12 weeks thereafter and up to 24 months. In summary, the aim of this trial is to demonstrate the clinical efficacy and safety of concurrent BR and apatinib in patients with driver mutation-negative NSCLC with multiple BMs, in efforts to expand management options for this population with poor prognosis.