一个随机控制的III期试验继续或暂停的PD-1通路阻塞在患有晚期细胞癌的患者 (JCOG1905,STOP研究):研究协议
Takashi Matsumoto1, Tokiyoshi Tanegashima1, Ario Takeuchi1
1Department of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Japanese journal of clinical oncology
|December 1, 2025
概括
在晚期细胞癌 (RCC) 中暂停PD-1阻断疗法可能与持续治疗一样有效. 这种方法可以减少癌患者的财务和毒性负担.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 临床试验 临床试验
背景情况:
- 免疫检查点阻塞 (ICBs),特别是PD-1通路抑制剂,已经改变了晚期细胞癌 (RCC) 治疗.
- 长期ICB治疗带来了重大的财务和毒性挑战.
- 追溯分析表明,治疗响应平原在24周左右,在停止治疗后可能持续控制疾病.
研究的目的:
- 确认暂停PD-1通路阻塞与在没有疾病进展的晚期清细胞RCC患者中持续给予的非劣质性.
- 评估间歇性PD-1封锁策略的可行性和有效性.
主要方法:
- 一个多机构,开放标签,随机对照试验 (第三阶段).
- 没有疾病进展的高级清晰细胞RCC患者被随机分配到暂停或继续PD-1阻塞.
- 主要终点:整体存活率. 二级终点:战略失败的时间,无进展的生存率和不良事件.
主要成果:
- 数据收集和分析正在进行中.
- 这项研究旨在确定是否可以通过暂停治疗策略实现整体存活的非劣势差.
结论:
- 这些发现将为高级RCC中PD-1阻塞的最佳治疗持续时间提供信息.
- 这项试验可以建立一个不那么繁重的治疗计划,改善患者的生活质量,降低医疗保健成本.
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