复合Kushen注射与第一线治疗相结合,与先进结直肠癌的单独第一线治疗相结合:多中心,开放标签,随机对照试验的研究方案
Jingyuan Wu1,2, Yuansha Ge1,2, Guanghui Zhu1
1Oncology Department, Guang'anmen Hospital, China, Academy of Chinese Medical Sciences, Beixian Pavilion, No.5, Xicheng District, Beijing, China.
BMC complementary medicine and therapies
|December 31, 2024
概括
这项研究评估了复合库申注射 (CKI) 与先进结直肠癌 (CRC) 的一线治疗相结合. 它旨在确定CKI是否可以改善CRC患者的无进展生存率和安全性.
科学领域:
- 在瘤学瘤学.
- 临床药理学 临床药理学
- 综合医学是一个整体的医学.
背景情况:
- 晚期结肠直肠癌 (CRC) 治疗疗效与目前的第一线疗法仍然低于最佳.
- 复合库申注射 (CKI) 是一种广泛使用的中国草药,用于中国的辅助癌症治疗.
- 需要评估CKI在改善高级CRC的结果中的作用.
研究的目的:
- 评估CKI与高级CRC的标准一线治疗相结合的疗效和安全性.
- 确定CKI对无进展生存 (PFS) 和整体生存 (OS) 的影响.
- 探索CRC治疗中CKI的潜在生物标志物和作用机制.
主要方法:
- 这是一项多中心,随机,开放的受控试验,涉及320名晚期CRC患者.
- 患者将接受标准的第一线化疗 (FOLFOX/FOLFIRI/CAPEOX±向药物),有或没有CKI.
- 主要终点是无进展生存 (PFS);次要终点包括OS,反应率和生活质量.
主要成果:
- 本部分应在研究完成后填写.
- 该研究旨在提供关于CKI临床益处的可靠数据.
- 安全结果,包括不良事件,将被仔细记录下来.
结论:
- 这是第一个随机对照试验,研究CKI与先进的CRC的第一线治疗相结合.
- 这项研究旨在确定CKI的临床优势和治疗效果.
- 生物标志物和奥米克分析将指导个性化治疗策略,并阐明CKI的机制.
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