CHARIOT:一项用于食道癌和其他固体癌症的berzosertib与化疗放射治疗的I期研究,使用时间到事件持续重新评估方法
S R Javed1, S Lord1, S El Badri1
1Department of Oncology, University of Oxford, Oxford, UK.
British journal of cancer
|December 21, 2023
概括
作为ATR抑制剂的伯佐瑟蒂布是安全的,并且可以与食道癌的放射治疗以及晚期癌症的化疗一起耐受. 建议进行进一步的第二阶段研究.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 贝尔佐瑟蒂布是一种强效和选择性的ATR抑制剂.
- 这项研究评估了berzosertib在食道癌与放射治疗和晚期固体瘤与化疗.
研究的目的:
- 评估贝尔佐瑟蒂布的安全性,初步疗效和耐受性.
- 为了确定Berzosertib在组合治疗方案中推的II期剂量 (RP2D).
主要方法:
- 单臂,开放标签剂量升级试验.
- 在食管癌队列 (A1) 中有16名患者,在高级固体瘤队列 (A2) 中有18名患者.
- 用于剂量升级的时间到事件持续重新评估方法.
主要成果:
- 在A1中具有RT的berzosertib的RP2D为240 mg/m2;没有观察到剂量限制性毒性 (DLTs).
- 在A2中,柏佐谢尔蒂布与思普拉丁和capecitabine的RP2D为每周140mg/m2;2名患者7次DLT.
- 最常见的≥3级不良事件包括皮疹,中性质减退和血小板减退;没有与治疗相关的死亡.
结论:
- 与RT结合的柏佐瑟蒂布在食道癌症中可行且耐受良好.
- 伯佐瑟蒂布与西斯普拉丁和卡佩奇塔宾一起在晚期癌症中耐受性良好.
- 在第二阶段设置下进行进一步调查是合理的.
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