Brucea javanica油乳液加上耐火性晚期结直肠癌的支持性护理:一个试点RCT协议
Liyuan Fang1, Yan Wang1, Yuhang Fang2
1Department of Oncology, Guang'anmen Hospital of the Chinese Academy of Traditional Chinese Medicine, Beijing, China.
Frontiers in pharmacology
|August 5, 2025
概括
这项研究调查了Brucea javanica油乳液注射 (BJOEI) 以及晚期结直肠癌患者的最佳支持性护理 (BSC). 它的目的是评估BJOEI.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
- 传统中国医药 传统中国医药
背景情况:
- 结肠直肠癌 (CRC) 是全球死亡率的一个重大挑战,特别是在转移阶段.
- 目前用于晚期CRC的治疗方法往往产生不理想的结果.
- 在临床实践中,Brucea javanica油乳液注射 (BJOEI) 已显示出作为辅助疗法的潜力.
研究的目的:
- 评估BJOEI与最好的支持性护理 (BSC) 结合的疗效和安全性,用于对所有现有疗法都不耐药的晚期结直肠癌患者.
- 收集初步数据,以支持未来的III期临床试验.
主要方法:
- 一个多中心的,随机的,受控的试验,涉及60名符合条件的参与者.
- 参与者被随机分配给接受BJOEI + BSC或仅接受BSC.
- 主要终点:无进展生存 (PFS);次要终点:临床症状,生活质量,整体生存 (OS) 和不良事件.
主要成果:
- 数据收集和分析正在进行中.
- 初步发现将为更大的III期试验的设计提供信息.
结论:
- 这是第一个探索传统中医作为治疗失败的晚期结直肠癌患者单一疗法的研究.
- 预计结果将为BJOEI在管理耐火CRC方面的作用提供新的见解.
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