Dynamic traditional Chinese medicine treatment strategies for advanced colorectal cancer based on umbrella trial design centered on master protocols

LI Rui; XU Yuying; LIU Jian; NING Chunhui; WANG Yansong; LU Meiji; ZHAI Jiawei; YANG Yufei

doi:10.16025/j.1674-1307.2025.05.026

您当前的位置：

首页 >

文章列表页 >

Dynamic traditional Chinese medicine treatment strategies for advanced colorectal cancer based on umbrella trial design centered on master protocols

更新时间：2025-07-07

- Dynamic traditional Chinese medicine treatment strategies for advanced colorectal cancer based on umbrella trial design centered on master protocols
- Beijing Journal of Traditional Chinese Medicine Vol. 44, Issue 5, Pages: 666-670(2025)
- 作者机构：
  
  1.中国中医科学院西苑医院肿瘤科，北京 100091
  2.北京中医药大学研究生学院，北京 100029
- 作者简介：
- 基金信息：
- DOI：10.16025/j.1674-1307.2025.05.026
  CLC：
- Received：28 February 2024，
  
  Published：25 May 2025
- 稿件说明：
移动端阅览
李芮，徐钰莹，刘健，等.基于主方案伞式试验设计的晚期结直肠癌中医动态治疗策略应用现状［J］.北京中医药，2025，44（5）：666-670.

LI Rui,XU Yuying,LIU Jian,et al.Dynamic traditional Chinese medicine treatment strategies for advanced colorectal cancer based on umbrella trial design centered on master protocols[J]. Beijing Journal of Traditional Chinese Medicine,2025,44(05):666-670.
李芮，徐钰莹，刘健，等.基于主方案伞式试验设计的晚期结直肠癌中医动态治疗策略应用现状［J］.北京中医药，2025，44（5）：666-670. DOI： 10.16025/j.1674-1307.2025.05.026.

LI Rui,XU Yuying,LIU Jian,et al.Dynamic traditional Chinese medicine treatment strategies for advanced colorectal cancer based on umbrella trial design centered on master protocols[J]. Beijing Journal of Traditional Chinese Medicine,2025,44(05):666-670. DOI： 10.16025/j.1674-1307.2025.05.026.

摘要

主方案伞式试验设计以“疾病特征为中心”，应用多种干预措施对同种疾病进行更有效的评估。中医思维的动态治疗策略、个性化诊疗特征与主方案伞式试验设计的理念相契合，将一种疾病的患者辨证为不同证型，根据各证型的病机加以用药。构建基于伞式试验设计方法的中医治疗动态策略，需要适应疾病发展阶段，不单靠中医或西医的简单治疗手段。中医肿瘤临床研究可借鉴伞式试验的设计思路，以晚期结直肠癌示例，在基线时根据辨证论治思路区分亚组，即进入肠癌伞式试验，在该设计方法中，根据中医及西医的治疗侧重分为纯中医、中西医并重及中医辅助西医这三种干预方式。这种试验设计不仅加快了研究进程，还提高了研究的质量和可靠性，减少了所需的样本量。

Abstract

With the ongoing advancement of precision medicine， innovative trial designs are beginning to supplant traditional clinical trial methodologies. Unlike standard designs， the intervention-centered approach diverges significantly， while the umbrella trial design emphasizes disease characteristics and employs multiple intervention strategies to more effectively assess the same condition. The dynamic treatment strategies inherent in traditional Chinese medicine， along with the principles of personalized diagnosis and treatment， align well with the umbrella experimental design framework. Patients diagnosed with a particular disease are categorized into distinct syndrome types， and treatment is tailored according to the unique pathogenesis associated with each syndrome. Developing a dynamic strategy for traditional Chinese medicine treatment， grounded in the umbrella experimental design， necessitates an adaptation to the disease's progression and cannot rely solely on simplistic treatment approaches from either traditional Chinese medicine or western medicine.

关键词

Keywords

references

于泽 , 叶璇 , 吕春明 , 等 . 真实世界拉帕替尼治疗乳腺癌预后预测研究 [J ] . 中国新药与临床杂志 , 2024 , 43 ( 1 ): 44 - 50 .

王红国 , 郑虹 , 高雨农 , 等 . 奥拉帕利在卵巢癌真实世界治疗中的不良反应 [J ] . 肿瘤药学 , 2023 , 13 ( 5 ): 597 - 603 .

孙源 , 张玲 . 主方案设计的研究方法在精准医学中的应用 [J ] . 中国循证医学杂志 , 2023 , 23 ( 4 ): 465 - 470 .

FOUNTZILAS E , TSIMBERIDOU AM , VO HH , et al . Clinical trial design in the era of precision medicine [J ] . Genome Med , 2022 , 14 ( 1 ): 101 .

于亚南 , 杜培艳 , 刘骏 , 等 . 精准医学创新性临床试验设计“主方案”研究的概念、设计与案例 [J ] . 中国新药杂志 , 2020 , 29 ( 23 ): 2712 - 2717 .

钱会南 . 同病异治的理论渊源与后世影响 [J ] . 中医研究 , 2023 , 36 ( 9 ): 1 - 4 .

韩立杰 . 关于中医异病同治理论的研究 [J ] . 中国社区医师 , 2020 , 36 ( 8 ): 93 - 94 .

SUNG H , FERLAY J , SIEGEL RL , et al . Global Cancer Statistics 2020: Globocan estimates of incidence and mortality worldwide for 36 cancers in 185 countries [J ] . CA Cancer J Clin , 2021 , 71 ( 3 ): 209 - 249 .

XIA C , DONG X , LI H , et al . Cancer Statistics in China and United States,2022: profiles, trends, and determinants [J ] . Chin Med J (Engl) , 2022 , 135 ( 5 ): 584 - 590 .

朱静 , 尚广彬 , 孙慧娟 , 等 . 结肠癌的中医病机分析及复方治疗探索 [J ] . 江西中医药 , 2018 , 49 ( 12 ): 75 - 78 .

孙凌云 , 闫蕴孜 , 徐钰莹 , 等 . 基于单中心回顾性真实世界研究的晚期结直肠癌三线中西医结合治疗现状及疗效分析 [J ] . 中医肿瘤学杂志 , 2022 , 4 ( 1 ): 18 - 23 .

PARK J , HSU G , SIDEN EG , et al . An overview of precision oncology basket and umbrella trials for clinicians [J ] . CA Cancer J Clin , 2020 , 70 ( 2 ): 125 - 137 .

毛元铭 , 詹瑨祺 , 王榕榕 , 等 . 临床医学试验主方案概述及其应用 [J ] . 中国新药杂志 , 2021 , 30 ( 22 ): 2083 - 2090 .

PARK J , HARARI O , DRON L , et al . An overview of platform trials with a checklist for clinical readers [J ] . J Clin Epidemiol , 2020 , 125 : 1 - 8 .

PARK J , SIDEN E , ZORATTI MJ , et al . Systematic review of basket trials, umbrella trials, and platform trials: a landscape analysis of master protocols [J ] . Trials , 2019 , 20 ( 1 ): 572 .

MIDDLETON G , FLETCHER P , POPAT S , et al . The national lung matrix trial of personalized therapy in lung cancer [J ] . Nature , 2020 , 583 ( 7818 ): 807 - 812 .

REDMAN MW , PAPADIMITRAKOPOULOU VA , MINICHIELLO K , et al . Biomarker-driven therapies for previously treated squamous non-small-cell lung cancer (Lung-MAP SWOG S1400): a biomarker-driven master protocol [J ] . Lancet Oncol , 2020 , 21 ( 12 ): 1589 - 1601 .

FERRAROTTO R , REDMAN MW , GANDARA DR , et al . Lung-MAP-framework, overview, and design principles [J ] . Chin Clin Oncol , 2015 , 4 ( 3 ): 36 .

WAQAR SN , REDMAN MW , ARNOLD SM , et al . A phase II study of telisotuzumab vedotin in patients with c-MET-positive stage IV or recurrent squamous cell lung cancer (LUNG-MAP Sub-study S1400K, NCT03574753) [J ] . Clin Lung Cancer , 2021 , 22 ( 3 ): 170 - 177 .

OWONIKOKO TK , REDMAN MW , BYERS LA , et al . Phase 2 study of talazoparib in patients with homologous recombination repair-deficient squamous cell lung cancer: Lung-MAP Substudy S1400G [J ] . Clin Lung Cancer , 2021 , 22 ( 3 ): 187 - 194, e 1 .

GOVINDAN R , MANDREKAR SJ , GERBER DE , et al . ALCHEMIST trials: a golden opportunity to transform outcomes in early-stage non-small cell lung cancer [J ] . Clin Cancer Res , 2015 , 21 ( 24 ): 5439 - 5444 .

TURNER NC , KINGSTON B , KILBURN LS , et al . Circulating tumour DNA analysis to direct therapy in advanced breast cancer (plasmaMATCH): a multicentre, multicohort, phase 2a, platform trial [J ] . Lancet Oncol , 2020 , 21 ( 10 ): 1296 - 1308 .

ADAMS R , BROWN E , BROWN L , et al . Inhibition of EGFR, HER2, and HER3 signalling in patients with colorectal cancer wild-type for BRAF, PIK3CA, KRAS, and NRAS (FOCUS4-D): a phase 2-3 randomised trial [J ] . Lancet Gastroenterol Hepatol , 2018 , 3 ( 3 ): 162 - 171 .

BURD A , LEVINE RL , RUPPERT AS , et al . Precision medicine treatment in acute myeloid leukemia using prospective genomic profiling: feasibility and preliminary efficacy of the beat AML master trial [J ] . Nat Med , 2020 , 26 ( 12 ): 1852 - 1858 .

郭晓慧 , 黄仟 , 谢雁鸣 , 等 . 伞式设计与篮式设计在中医药循证评价中的应用 [J ] . 中国中药杂志 , 2021 , 46 ( 8 ): 2010 - 2015 .

张成 , 王玉光 , 闫世艳 . 主方案伞式设计在中医药临床研究中的应用 [J ] . 北京中医药 , 2023 , 42 ( 5 ): 487 - 490 .

赵晨 , 张晓雨 , 胡嘉元 , 等 . 中医同证候系疾病临床研究母方案设计方法 [J ] . 中医杂志 , 2018 , 59 ( 2 ): 111 - 115 .

周海金 . 道家与中医 [J ] . 南京中医药大学学报(社会科学版) , 2007 , 8 ( 1 ): 34 - 37 .

徐钰莹 . 晚期结直肠癌中医优势人群判别模型的建立与动态治疗策略的探索 [D ] . 北京 : 北京中医药大学 , 2021 .

田园 , 杨忠明 , 衡鑫 , 等 . 中医药联合化疗和靶向治疗晚期肠癌的研究进展 [J ] . 中药药理与临床 , 2024 , 40 ( 3 ): 119 - 123 .

胡金焕 , 刘经选 , 王兰 , 等 . 扶正祛瘀解毒配方颗粒辅助化疗对晚期结直肠癌患者免疫功能和生活质量的影响 [J ] . 中药新药与临床药理 , 2021 , 32 ( 8 ): 1211 - 1216 .

李道生 , 曾祥胜 , 王逸飞 , 等 . 复方斑蝥胶囊改善晚期结直肠癌化疗后疲乏临床价值 [J ] . 中医药临床杂志 , 2021 , 33 ( 11 ): 2235 - 2237 .

Views

下载量

CSCD

Alert me when the article has been cited

提交

Tools

Publicity Resources

No data

Related Author

No data

Related Institution

No data

⁰