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Prospective Study
Copyright: ©Author(s) 2026. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution-NonCommercial (CC BY-NC 4.0) license. No commercial re-use. See permissions. Published by Baishideng Publishing Group Inc.
World J Clin Oncol. Jun 24, 2026; 17(6): 119607
Published online Jun 24, 2026. doi: 10.5306/wjco.119607
Clinical study of Xianjun formula combined with standard western therapy in metastatic colorectal cancer
Lin-Feng Wang, Yu-Xing Sun, Jiang-Yu Bian, Tong Zhang
Lin-Feng Wang, Yu-Xing Sun, Jiang-Yu Bian, Tong Zhang, Department of Oncology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China
Author contributions: Wang LF contributed to literature investigation, drafting of the initial manuscript, and final manuscript integration; Sun YX and Bian JY contributed to partial literature retrieval, data curation, and manuscript revision; Zhang T was responsible for the conception and design of the research topic, and the final review and proofreading; and all authors have read and approved the final manuscript.
AI contribution statement: Grammar-checking and spell-checking functions (e.g., the builtin review tools in Microsoft Word) were used. No generative AI tools such as ChatGPT or DeepL were used to generate scientific content. The point-by-point response to the reviewers’ comments, including the description of the revised content and its specific location in the paper, was written by the authors. We referred to multiple publicly available online response templates for comprehensive sorting, then used DeepL for translation and language polishing. All scientific and technical details are entirely our own research achievements.
Supported by Capacity Enhancement Program of Xiyuan Hospital, China Academy of Traditional Chinese Medicine, No. XYZX0201-22.
Institutional review board statement: The study has been approved by the Ethics Committee of Xiyuan Hospital, China Academy of Chinese Medical Sciences, Approval No. 2025XLA172-2.
Clinical trial registration statement: This study has been registered at the International Traditional Medicine Clinical Trial Registry. The registration number is ITMCTR2026001027.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Data sharing statement: No additional data are available.
Corresponding author: Tong Zhang, MD, PhD, Associate Chief Physician, Department of Oncology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, No. 1 Xiyuan Playground, Haidian District, Beijing 100091, China. ashtray7654@126.com
Received: February 2, 2026
Revised: March 11, 2026
Accepted: May 11, 2026
Published online: June 24, 2026
Processing time: 141 Days and 16.8 Hours
Core Tip

Core Tip: Most metastatic colorectal cancer (mCRC) patients are microsatellite stable (MSS) and derive limited benefit from immune checkpoint inhibitor-based therapies, especially in late-line settings. This prospective, multicenter, single-arm clinical trial explores the feasibility and survival benefit of integrating Xianjun formula, a traditional Chinese medicine compound, with standard Western therapies in refractory MSS mCRC. By targeting the tumor immune microenvironment, this study aims to provide preliminary clinical evidence supporting an integrative therapeutic strategy for patients lacking effective treatment options.

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