用于治疗晚期耐火性结直肠癌的Sijunzi颗粒:多中心,随机,双盲,安慰剂对照试验的研究方案
Shuchang Nie1, Yingyu Su1, Lu Lu1,2,3
1Institute of Digestive Diseases, Longhua Hospital, China-Canada Center of Research for Digestive Diseases (ccCRDD), Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Frontiers in medicine
|April 4, 2025
概括
这项研究研究了Sijunzi (SJZD) 针对晚期耐火性结直肠癌 (CRC). 它旨在提供证据,以整合中国传统医学与西方治疗方法,以改善CRC患者的治疗结果.
科学领域:
- 在瘤学瘤学.
- 胃肠病学 胃肠病学
- 综合医学是一个整体的医学.
背景情况:
- 结肠直肠癌 (CRC) 的发病率和死亡率在全球范围内不断上升,晚期的预后不佳.
- 传统的CRC治疗方法面临着诸如耐药性和严重副作用等挑战.
- 传统中医药 (TCM) 配方Sijunzi开 (SJZD) 在CRC治疗中显示出前景.
研究的目的:
- 评估SJZD与高级耐火性CRC标准治疗相结合的疗效.
- 为整合TCM和西方医学在CRC管理中提供临床证据.
- 探索SJZD在改善难以治疗的CRC病例治疗结果方面的潜力.
主要方法:
- 一个多中心,随机,双盲,安慰剂受控试验.
- 晚期耐火性CRC患者将接受SJZD加标准治疗或安慰剂加标准治疗.
- 主要终点是无进展生存 (PFS),次要结果包括整体生存 (OS) 和生活质量.
主要成果:
- 这一部分应在试验结果可用后填写.
结论:
- 这项试验代表了SJZD对先进耐火性CRC的首次临床研究.
- 预计结果将为TCM融入标准CRC护理提供信息.
- 这项研究旨在确定SJZD作为耐火性CRC的可行治疗选择.
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