[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100503373":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":60,"collaborators":63,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":25,"eligibilityCriteria":79,"healthyVolunteers":76,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":25,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Shanghai University of Traditional Chinese Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"chemotherapy plus TCM 1&ICIs plusTCM2","EXPERIMENTAL","Phase1： Chemotherapy：Proposed platinum-containing two-drug adjuvant chemotherapy, vincristine\u002Fpaclitaxel\u002Fdocetaxel\u002Fpemetrexed\u002Fgemcitabine plus cisplatin\u002Fcarboplatin within 8 weeks after surgery, according to CSCO guidelines (2022).\n\nTCM1 granules：oral granules, \"HeWeiYangXueFang\" , twice a day, every 21 days for 4 cycles.\n\nPhase 2： One of the following agents may be selected after chemotherapy ：Nivolumab\u002FPembrolizumab\u002FDurvalumab\u002FAtezolizumab\u002F Camrelizumab\u002FDupilumab\u002FSintilimab\u002FTislelizumab.A total of 12 cycles will be performed or the patient will discontinue the drug due to intolerable toxic side effects.\n\nTCM2 granules：oral granules, \"FeiPingFang\" , twice a day, every 21 days for 12 cycles.",[13],"Drug: chemotherapy plus TCM 1&ICIs plusTCM2",{"label":15,"type":16,"description":17,"interventionNames":18},"chemotherapy plus TCM 1 placebo&ICIs plus TCM2 placebo","PLACEBO_COMPARATOR","Phase1： Chemotherapy：Proposed platinum-containing two-drug adjuvant chemotherapy, vincristine\u002Fpaclitaxel\u002Fdocetaxel\u002Fpemetrexed\u002Fgemcitabine plus cisplatin\u002Fcarboplatin within 8 weeks after surgery, according to CSCO guidelines (2022).\n\nPlacebo1 granules: oral granules, which the taste and smell are similar to experimental TCM granules and has no therapeutic effect , twice a day, every 21 days for 4 cycles.\n\nPhase 2：One of the following agents may be selected after chemotherapy：Nivolumab\u002FPembrolizumab\u002FDurvalumab\u002FAtezolizumab\u002F Camrelizumab\u002FDupilumab\u002FSintilimab\u002FTislelizumab.A total of 12 cycles will be performed or the patient will discontinue the drug due to intolerable toxic side effects.\n\nPlacebo2 granules: oral granules, which the taste and smell are similar to experimental TCM granules and has no therapeutic effect, twice a day, every 21 days for 12 cycles.",[19],"Drug: chemotherapy plus TCM 1placebo &ICIs plus TCM2 placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","In China,TCM herbs are given on the basis of the TCM syndrome differentiation as diagnosed by the TCM herbal specialist. Prescriptions formulated into granules origin from Professor Liu Jia-xiang and Xu Ling. Package of granules is made into two types with functions such as tonifying the stomach and nourishing the blood recipe, benefiting Qi Yin and detoxification and resolving masses recipe. The herbal treatment is adapted to the syndromes.\n\nChemotherapy：Vincristine\u002Fpaclitaxel\u002Fdocetaxel\u002Fpemetrexed\u002Fgemcitabine plus cisplatin\u002Fcarboplatin：administrated for patients with NSCLC requiring post-operative adjuvant therapy.\n\nICIs：Nivolumab\u002FPembrolizumab\u002FDurvalumab\u002FAtezolizumab\u002F Camrelizumab\u002FDupilumab\u002FSintilimab\u002FTislelizumab：administrated for patients with NSCLC requiring post-operative adjuvant therapy.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"chemotherapy plus TCM 1placebo &ICIs plus TCM2 placebo","Chemotherapy：Vincristine\u002Fpaclitaxel\u002Fdocetaxel\u002Fpemetrexed\u002Fgemcitabine plus cisplatin\u002Fcarboplatin：administrated for patients with NSCLC requiring post-operative adjuvant therapy.\n\nICIs：Nivolumab\u002FPembrolizumab\u002FDurvalumab\u002FAtezolizumab\u002F Camrelizumab\u002FDupilumab\u002FSintilimab\u002FTislelizumab：administrated for patients with NSCLC requiring post-operative adjuvant therapy.",[15],[31],{"name":32,"affiliation":5,"role":33},"Ling Ling, MD & PhD","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Ling Xu, MD & PhD","CONTACT","86+021-65161782-1662","xulq67@aliyun.com",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"YueYang Hosptial of Intergrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine","RECRUITING","Shanghai","Shanghai Municipality","200437","China","CN",{"type":50,"coordinates":51},"Point",[52,53],121.45806,31.22222,{"lat":53,"lon":52},[56],{"name":57,"role":37,"phone":58,"phoneExt":25,"email":59},"Yin","86+021-65161782-6160","yyyyllwyh@163.com",{"type":33,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Ling Xu","Chief Physician",[64,66,68,70,72],{"name":65,"class":6},"Shanghai Pulmonary Hospital, Shanghai, China",{"name":67,"class":6},"Shanghai Chest Hospital",{"name":69,"class":6},"Fudan University",{"name":71,"class":6},"Shanghai Zhongshan Hospital",{"name":73,"class":6},"Ruijin Hospital","100503373","clinical-study-on-the-prevention-of-driver-gene-negative-ib-iiib-lung-cancer-recurrence-and-metastasis-by-staged-chinese-herbal-medicine-combined-with-chemotherapy-and-immune-checkpoint-inhibitors-100503373",false,"NCT05834413","Clinical Study on the Prevention of Driver Gene Negative Ib-IIIb Lung Cancer Recurrence and Metastasis by Staged Chinese Herbal Medicine Combined With Chemotherapy and Immune Checkpoint Inhibitors","Inclusion Criteria:\n\n1. Patients who underwent complete surgical resection (R0) with postoperative pathology confirmed as stage Ib to IIIb non-small cell lung cancer.\n2. Patients whose tissue or blood specimens tested negative for driver genes.\n3. Patients who received their first chemotherapy within 8 weeks postoperatively.\n4. Age ≥ 18 years ≤ 74 years, regardless of gender.\n5. Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 2 points.\n6. absolute neutrophil value \\>1.5×109 \u002FL, platelet count \\>80×109 \u002FL, hemoglobin \\>90mg\u002FdL; no abnormal liver and kidney function test results.\n7. Understand and agree to participate in this study and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Having unresectable or metastatic disease, pathology reports without a clear pathological diagnosis, showing the presence of residual lesions at the microscopic surgical margins, and surgical residual lesions.\n2. Any medical condition with a life expectancy of less than 5 years, except for risk of recurrent lung cancer.\n3. Current malignant disease or history of malignant disease (except resected NSCLC), combined with serious diseases of the heart, liver, kidney and hematopoietic system, diagnosed and\u002For requiring treatment within the past three years.\n4. With a history of psychiatric disorders that are not easily controlled.\n5. Patients who are pregnant or lactating.\n6. Patients who are allergic to therapeutic drugs.","ALL","18 Years","74 Years",{"count":84,"type":85},367,"ESTIMATED","INTERVENTIONAL",[88],"NA","This project adopts a prospective, multicenter, randomized controlled clinical study to investigate the treatment of TCM in postoperative patients with driver gene negative lung cancer, according to two phases of postoperative adjuvant therapy: (i) chemotherapy phase immunotherapy phase. In this study, 367 patients (183 in the control group and 184 in the trial group) will be observed over 4 years, and the quality of life, toxic effects and safety of this therapy will be investigated. This study will provide evidence-based evidence for the establishment and optimization of a new model of postoperative staged TCM with adjuvant chemo-immunotherapy for lung cancer.",[91],"Lung Cancer",[93,94,95,96],"non-small cell lung cancer","traditional Chinese medicine","postoperative adjuvant therapy","immune checkpoint inhibitors","2026-05-08",{"date":99,"type":100},"2026-05-13","ACTUAL",{"date":102,"type":100},"2023-05-01",{"date":104,"type":85},"2027-06-30",{"name":5,"class":6},1]