对于转移性结直肠癌患者的capecitabine计量化疗达到NED:前性随机对照试验的协议
Jiaming Wu1,2, Yu Dong3, Wanshan Zhu1
1Zhongshan Hospital of Traditional Chinese Medicine Affiliated to Guangzhou University of Chinese Medicine, Zhongshan, China.
PloS one
|April 21, 2025
概括
目前正在研究作为一种维持治疗方法,用于转移性结肠直肠癌 (mCRC) 患者,这些患者没有达到疾病的证据 (NED). 这项试验将评估与标准随访相比,其有效性和安全性.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 药理学 药理学是指药理学的学科.
背景情况:
- 越来越多的转移性结直肠癌 (mCRC) 患者在治疗后没有疾病状态 (NED) 的证据.
- 目前的指南缺乏针对NED mCRC患者的具体治疗建议.
- 由于疗效和安全性,capecitabine计量化疗对维持疗法具有前景,但缺乏RCT数据.
研究的目的:
- 为了评估capecitabine计量化疗对mCRC患者在NED状态中的疗效和安全性.
- 为了比较capecitabine计量化疗与NED mCRC患者的"观看和等待"方法.
主要方法:
- 一个前性,随机对照试验,有240名参与者.
- 患有IV期mCRC的参与者在切除/切除后达到NED状态,随机分配给capecitabine (2年两次500 mg/m2) 或"观察和等待".
- 主要结局:无病生存 (DFS);次要结局:整体生存 (OS),生存率和不良事件.
主要成果:
- 这个部分在研究结束后要填写.
结论:
- 这项试验将为NED mCRC患者的capecitabine计量化疗的疗效和安全提供关键证据.
- 结果将为这种患者群体提供潜在的新维持治疗策略.
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