{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,2]],"date-time":"2026-05-02T04:20:22Z","timestamp":1777695622487,"version":"3.51.4"},"reference-count":71,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2026,3,1]],"date-time":"2026-03-01T00:00:00Z","timestamp":1772323200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,3,1]],"date-time":"2026-03-01T00:00:00Z","timestamp":1772323200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"The Project of State Key Laboratory of Traditional Chinese Medicine Syndrome","award":["SKLKY2024B0002Z"],"award-info":[{"award-number":["SKLKY2024B0002Z"]}]},{"DOI":"10.13039\/501100020084","name":"guangzhou municipal science and technology bureau","doi-asserted-by":"publisher","award":["2024A03J0709, 2025A03J3156"],"award-info":[{"award-number":["2024A03J0709, 2025A03J3156"]}],"id":[{"id":"10.13039\/501100020084","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100010618","name":"guangzhou university of chinese medicine","doi-asserted-by":"publisher","award":["SZ2021ZZ40"],"award-info":[{"award-number":["SZ2021ZZ40"]}],"id":[{"id":"10.13039\/501100010618","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100010618","name":"guangzhou university of chinese medicine","doi-asserted-by":"publisher","award":["SZ2023ZZ14"],"award-info":[{"award-number":["SZ2023ZZ14"]}],"id":[{"id":"10.13039\/501100010618","id-type":"DOI","asserted-by":"publisher"}]},{"name":"The Traditional Chinese Medicine Bureau of Guangdong Province","award":["20254059"],"award-info":[{"award-number":["20254059"]}]},{"DOI":"10.13039\/100012829","name":"guangdong provincial hospital of traditional chinese medicine","doi-asserted-by":"publisher","award":["YN2023MS32"],"award-info":[{"award-number":["YN2023MS32"]}],"id":[{"id":"10.13039\/100012829","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100012245","name":"Science and Technology Planning Project of Guangdong Province","doi-asserted-by":"publisher","award":["No.2023B1212060063"],"award-info":[{"award-number":["No.2023B1212060063"]}],"id":[{"id":"10.13039\/501100012245","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Integr Cancer Ther"],"published-print":{"date-parts":[[2026,3]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Colorectal cancer is one of the most common and fatal cancers worldwide. Despite therapeutic advancements, patients with stage II and III colon cancer often experience recurrences and metastases, particularly to the liver, leading to suboptimal disease-free survival (DFS) rates and decreased long-term survival. Qu-Shi-Jie-Du decoction (QSJDD), a traditional Chinese herbal formula, may prevent cancer recurrence and spread by boosting immunity, reducing inflammation, and inhibiting tumour growth. Preliminary studies have demonstrated that QSJDD reduces liver metastasis in patients with colon cancer. However, robust clinical evidence is required to confirm its efficacy and safety.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>This study aims to evaluate the safety and efficacy of QSJDD in preventing colon cancer recurrence and liver metastasis, thereby offering a potential adjunctive therapy to improve patient outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>This multicentre, double-blind, randomised, placebo-controlled trial involves 336 high-risk stage II or III colon cancer patients from 10 Chinese hospitals. Post-surgery and chemotherapy, 168 patients will receive either QSJDD compound granules or a placebo for 6\u2009months, with a 3-year follow-up and evaluations every 6\u2009months. The primary endpoint is to measure the 3-year DFS rate, while secondary endpoints include 1- and 2-year DFS rates, overall survival, and changes in the Traditional Chinese Medicine Dampness Syndrome Scale. Safety and adverse events will be tracked, and blood and gut microbiomes will be analysed to assess QSJDD\u2019s impact on delaying colon cancer metastasis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion:<\/jats:title>\n                    <jats:p>This trial will determine the efficacy and safety of QSJDD and provide evidence regarding its role in the adjuvant treatment of colon cancer.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/15347354251396002","type":"journal-article","created":{"date-parts":[[2026,3,11]],"date-time":"2026-03-11T10:13:48Z","timestamp":1773224028000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Qu-Shi-Jie-Du Decoction for Prevention of Recurrence and Metastasis in High-Risk Stage II\/III Colon Cancer: Study Protocol for a Double-Blind, Randomized, Placebo-Controlled Trial"],"prefix":"10.1177","volume":"25","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7799-9356","authenticated-orcid":false,"given":"Ya-dong","family":"Chen","sequence":"first","affiliation":[{"name":"The Second Clinical College of Guangzhou University of Chinese Medicine, China"},{"name":"Department of Oncology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China"},{"name":"Guangzhou Key Laboratory of Acupuncture and Medicine Research, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-1098-7822","authenticated-orcid":false,"given":"Zi-yan","family":"He","sequence":"additional","affiliation":[{"name":"The Second Clinical College of Guangzhou University of Chinese Medicine, China"},{"name":"Department of Oncology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wen-jie","family":"Zhao","sequence":"additional","affiliation":[{"name":"The Second Clinical College of Guangzhou University of Chinese Medicine, China"},{"name":"Department of Oncology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China"},{"name":"Guangzhou Key Laboratory of Acupuncture and Medicine Research, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yi-han","family":"He","sequence":"additional","affiliation":[{"name":"The Second Clinical College of Guangzhou University of Chinese Medicine, China"},{"name":"Department of Oncology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China"},{"name":"Guangzhou Key Laboratory of Acupuncture and Medicine Research, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yi-hong","family":"Liu","sequence":"additional","affiliation":[{"name":"The Second Clinical College of Guangzhou University of Chinese Medicine, China"},{"name":"Department of Oncology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1956-7774","authenticated-orcid":false,"given":"Yan-juan","family":"Zhu","sequence":"additional","affiliation":[{"name":"The Second Clinical College of Guangzhou University of Chinese Medicine, China"},{"name":"Department of Oncology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China"},{"name":"Guangzhou Key Laboratory of Acupuncture and Medicine Research, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ya-ya","family":"Yu","sequence":"additional","affiliation":[{"name":"The Second Clinical College of Guangzhou University of Chinese Medicine, China"},{"name":"Department of Oncology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China"},{"name":"Guangzhou Key Laboratory of Acupuncture and Medicine Research, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhen-zhen","family":"Xiao","sequence":"additional","affiliation":[{"name":"The Second Clinical College of Guangzhou University of Chinese Medicine, China"},{"name":"Department of Oncology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China"},{"name":"Guangzhou Key Laboratory of Acupuncture and Medicine Research, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3284-2451","authenticated-orcid":false,"given":"Xue-song","family":"Chang","sequence":"additional","affiliation":[{"name":"The Second Clinical College of Guangzhou University of Chinese Medicine, China"},{"name":"Department of Oncology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China"},{"name":"Guangzhou Key Laboratory of Acupuncture and Medicine Research, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zong-bin","family":"Liu","sequence":"additional","affiliation":[{"name":"Shenzhen Zigzag Biotechnology Co., Ltd., China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8104-4280","authenticated-orcid":false,"given":"Hai-bo","family":"Zhang","sequence":"additional","affiliation":[{"name":"The Second Clinical College of Guangzhou University of Chinese Medicine, China"},{"name":"Department of Oncology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China"},{"name":"Guangzhou Key Laboratory of Acupuncture and Medicine Research, China"},{"name":"Guangdong Provincial Key Laboratory of Clinical Research on Traditional Chinese Medicine Syndrome, Guangzhou, China"},{"name":"State Key Laboratory of Traditional Chinese Medicine Syndrome, Guangzhou, China"},{"name":"State Key Laboratory of Dampness Syndrome of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2026,3,11]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21834"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/S2468-2667(21)00157-2"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2015.63.4238"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.6004\/jnccn.2021.0012"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoncol.2019.6486"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(20)30527-1"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1713709"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2407-14-810"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cson.2023.100013"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cell.2006.11.001"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.16073\/j.cnki.cjcpt.2021.13.12"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1093\/jncimonographs\/lgx015"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1007\/s11655-008-0251-9"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1155\/2022\/8529395"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.18632\/oncotarget.14567"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.3389\/fonc.2021.618793"},{"issue":"3","key":"e_1_3_3_18_2","first-page":"837","article-title":"Research on TCM syndrome regularities of colorectal cancer","volume":"31","author":"Wang GJ","year":"2016","unstructured":"Wang GJ, Yu WY. Research on TCM syndrome regularities of colorectal cancer. China J Tradit Chin Med Pharm. 2016;31(3):837-840.","journal-title":"China J Tradit Chin Med Pharm"},{"key":"e_1_3_3_19_2","volume-title":"Evidence-Based Clinical Chinese Medicine: Volume 17: Colorectal Cancer","author":"May BH","year":"2020","unstructured":"May BH, Liu Y. Evidence-Based Clinical Chinese Medicine: Volume 17: Colorectal Cancer. World Scientific; 2020."},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.e7586"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.7326\/M17-1067"},{"key":"e_1_3_3_22_2","doi-asserted-by":"publisher","DOI":"10.6004\/jnccn.2024.0029"},{"key":"e_1_3_3_23_2","doi-asserted-by":"publisher","DOI":"10.1039\/d1lc00360g"},{"key":"e_1_3_3_24_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00431-024-05896-7"},{"key":"e_1_3_3_25_2","doi-asserted-by":"crossref","unstructured":"Chen X Yuan X Chen Y et al. Circulating cell-in-cell tumor cells with neutrophil signature are hematogenous metastasis-initiating cells. Published online April 8 2024. http:\/\/dx.doi.org\/10.2139\/ssrn.4781922","DOI":"10.2139\/ssrn.4781922"},{"key":"e_1_3_3_26_2","unstructured":"US Food and Drug Administration. Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics: Guidance for Industry. US Department of Health and Human Services; 2023. Accessed May 17 2025. https:\/\/www.fda.gov\/media\/71195\/download"},{"key":"e_1_3_3_27_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2005.01.6071"},{"issue":"19","key":"e_1_3_3_28_2","first-page":"1677","article-title":"Development and preliminary optimization of the dampness syndrome scale of Chinese medicine","volume":"62","author":"Lu T","year":"2021","unstructured":"Lu T, Xie Q, Cai J, Yin L, Yuan J, Huang L, et al. Development and preliminary optimization of the dampness syndrome scale of Chinese medicine. J Tradit Chin Med. 2021;62(19):1677-1683.","journal-title":"J Tradit Chin Med"},{"issue":"7","key":"e_1_3_3_29_2","first-page":"2281","article-title":"Research on normatively portraying the symptom terminology of the dampness syndrome","volume":"25","author":"Li Q","year":"2023","unstructured":"Li Q, Wu W, Yang X. Research on normatively portraying the symptom terminology of the dampness syndrome. Mod Tradit Chin Med Mater Med. 2023;25(7):2281-2286.","journal-title":"Mod Tradit Chin Med Mater Med"},{"key":"e_1_3_3_30_2","doi-asserted-by":"publisher","DOI":"10.2147\/PPA.S468732"},{"key":"e_1_3_3_31_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2007.15.8923"},{"key":"e_1_3_3_32_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.currproblcancer.2017.11.002"},{"key":"e_1_3_3_33_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0274282"},{"key":"e_1_3_3_34_2","unstructured":"US Department of Health and Human Services; National Institutes of Health; National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE). Version 5.0. US Department of Health and Human Services; 2017. Accessed May 17 2025. https:\/\/ctep.cancer.gov\/protocolDevelopment\/electronic_applications\/ctc.htm"},{"key":"e_1_3_3_35_2","unstructured":"International Council for Harmonisation. ICH Harmonised Guideline: Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). Published November 9 2016. Accessed May 17 2025. https:\/\/database.ich.org\/sites\/default\/files\/E6_R2_Addendum.pdf"},{"key":"e_1_3_3_36_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa032709"},{"key":"e_1_3_3_37_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2006.08.2974"},{"key":"e_1_3_3_38_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(18)30093-7"},{"key":"e_1_3_3_39_2","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21830"},{"key":"e_1_3_3_40_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jncc.2024.01.006"},{"key":"e_1_3_3_41_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2024.114207"},{"key":"e_1_3_3_42_2","doi-asserted-by":"publisher","DOI":"10.1007\/BF02050346"},{"key":"e_1_3_3_43_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2009.1112"},{"key":"e_1_3_3_44_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(10)61543-7"},{"key":"e_1_3_3_45_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(12)70112-2"},{"key":"e_1_3_3_46_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(12)60209-8"},{"key":"e_1_3_3_47_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2021.2454"},{"key":"e_1_3_3_48_2","doi-asserted-by":"publisher","DOI":"10.1097\/PPO.0000000000000197"},{"key":"e_1_3_3_49_2","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdx109"},{"key":"e_1_3_3_50_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2019.2210"},{"key":"e_1_3_3_51_2","doi-asserted-by":"publisher","DOI":"10.1002\/ijc.29720"},{"key":"e_1_3_3_52_2","doi-asserted-by":"publisher","DOI":"10.18632\/oncotarget.14688"},{"key":"e_1_3_3_53_2","doi-asserted-by":"publisher","DOI":"10.1634\/theoncologist.2018-0442"},{"key":"e_1_3_3_54_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2022.02.005"},{"key":"e_1_3_3_55_2","doi-asserted-by":"publisher","DOI":"10.1142\/S0192415X21500385"},{"key":"e_1_3_3_56_2","doi-asserted-by":"publisher","DOI":"10.7150\/jca.87719"},{"key":"e_1_3_3_57_2","doi-asserted-by":"publisher","DOI":"10.1186\/s13020-023-00719-7"},{"key":"e_1_3_3_58_2","doi-asserted-by":"publisher","DOI":"10.1177\/1534735420972486"},{"key":"e_1_3_3_59_2","doi-asserted-by":"publisher","DOI":"10.1002\/med.21989"},{"key":"e_1_3_3_60_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jep.2024.119096"},{"key":"e_1_3_3_61_2","doi-asserted-by":"publisher","DOI":"10.1097\/SLA.0b013e31825b3a2b"},{"key":"e_1_3_3_62_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-019-0584-2"},{"key":"e_1_3_3_63_2","doi-asserted-by":"publisher","DOI":"10.6004\/jnccn.2022.0051"},{"key":"e_1_3_3_64_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12906-023-04052-2"},{"key":"e_1_3_3_65_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.addr.2017.12.005"},{"key":"e_1_3_3_66_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.canlet.2014.12.024"},{"key":"e_1_3_3_67_2","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.95.8.4589"},{"key":"e_1_3_3_68_2","doi-asserted-by":"publisher","DOI":"10.3390\/cancers12040896"},{"key":"e_1_3_3_69_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12943-024-02063-2"},{"key":"e_1_3_3_70_2","doi-asserted-by":"publisher","DOI":"10.1155\/2017\/9474532"},{"key":"e_1_3_3_71_2","doi-asserted-by":"publisher","DOI":"10.2147\/CMAR.S316544"},{"key":"e_1_3_3_72_2","doi-asserted-by":"publisher","DOI":"10.1177\/1534735419883687"}],"container-title":["Integrative Cancer Therapies"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/15347354251396002","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/15347354251396002","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/15347354251396002","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T09:18:00Z","timestamp":1777454280000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/15347354251396002"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,3]]},"references-count":71,"alternative-id":["10.1177\/15347354251396002"],"URL":"https:\/\/doi.org\/10.1177\/15347354251396002","relation":{},"ISSN":["1534-7354","1552-695X"],"issn-type":[{"value":"1534-7354","type":"print"},{"value":"1552-695X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,3]]},"article-number":"15347354251396002"}}