protocolSection identificationModule nctId: NCT06381960, orgStudyIdInfo id: 2022LJ014, briefTitle: Clinical Study on the Prevention and Treatment of Postoperative Metastasis of Lung Cancer by Fuzheng Quxie Recipe, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Jianhui Tian, class: OTHER, descriptionModule briefSummary: To address the clinical challenge of postoperative metastasis in stage IIA-IIIA non-small cell lung cancer with negative driver gene expression, there is a lack of effective diagnostic and therapeutic measures. Based on this, investigators propose to carry out a clinical study on the prevention and treatment of postoperative metastasis of IIA-IIIA stage lung cancer with negative driver gene expression with the formula of supporting the positive and dispelling the evil., conditionsModule conditions: Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 356, type: ESTIMATED, armsInterventionsModule interventions name: Fuzheng Quxie Recipe, outcomesModule primaryOutcomes measure: Disease-free survival, DFS, secondaryOutcomes measure: Overall survival,OS, secondaryOutcomes measure: Minimal residual disease, MRD, secondaryOutcomes measure: Circulating Tumour Cell Assay, secondaryOutcomes measure: Chinese Medicine Symptom Score, secondaryOutcomes measure: Quality of life assessment, secondaryOutcomes measure: Immunological indicators, secondaryOutcomes measure: Tumour marker, secondaryOutcomes measure: Peripheral blood systemic immunoinflammatory index, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Chest Hospital, status: RECRUITING, city: Changning, state: Shanghai, country: China, contacts name: Tianhui Tian, role: CONTACT, phone: +8613816562972, email: tjhhawk@shutcm.edu.cn, contacts name: Fan Xu, role: CONTACT, phone: +8618762866303, email: 1183596839@qq.com, locations facility: Shanghai General Hospital, status: RECRUITING, city: Hongkou, state: Shanghai, country: China, contacts name: Tianhui Tian, role: CONTACT, phone: +8613816562972, email: tjhhawk@shutcm.edu.cn, contacts name: Fan Xu, role: CONTACT, phone: 18762866303, email: 1183596839@qq.com, locations facility: Shanghai Traditional Chinese Medicine-Integrated Hospital, status: RECRUITING, city: Hongkou, state: Shanghai, country: China, contacts name: Tianhui Tian, role: CONTACT, phone: +8613816562972, email: tjhhawk@shutcm.edu.cn, contacts name: Fan Xu, role: CONTACT, phone: +8618762866303, email: 1183596839@qq.com, locations facility: Shanghai Municipal Hospital of Traditional Chinese Medicine, status: RECRUITING, city: Jing'an, state: Shanghai, zip: 200071, country: China, contacts name: Tianhui Tian, Professor, role: CONTACT, phone: +8613816562972, email: tjhhawk@shutcm.edu.cn, contacts name: Fan Xu, Dr, role: CONTACT, phone: 18762866303, email: 1183596839@qq.com, locations facility: Shanghai Pulmonary Hospital, status: RECRUITING, city: Yangpu, state: Shanghai, country: China, contacts name: Tianhui Tian, role: CONTACT, phone: +8613816562972, email: tjhhawk@shutcm.edu.cn, contacts name: Fan Xu, role: CONTACT, phone: +8618762866303, email: 1183596839@qq.com, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2022-12-21, uploadDate: 2024-04-18T10:13, filename: Prot_000.pdf, size: 825047, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2022-12-21, uploadDate: 2024-04-18T10:14, filename: ICF_001.pdf, size: 151196, hasResults: False