[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525420":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":40,"centralContacts":45,"locations":54,"responsibleParty":130,"collaborators":133,"id":137,"slug":39,"hasResults":138,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":39,"eligibilityCriteria":142,"healthyVolunteers":138,"sex":143,"minAge":144,"maxAge":145,"enrollmentInfo":146,"targetDuration":39,"studyType":149,"phases":150,"briefSummary":152,"conditions":153,"keywords":155,"overallStatus":57,"whyStopped":39,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},{"fullName":5,"class":6},"Sichuan University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Radiotherapy combined with sintilimab and chemotherapy","EXPERIMENTAL","Subjects received radiotherapy (SBRT+LDRT). Sintilimab combined with standard platinum-containing double-drug chemotherapy was performed within 1 week after the end of radiotherapy.",[13,14,15],"Radiation: low-dose radiation therapy and stereotactic body radiation therapy","Drug: chemotherapy","Drug: Sintilimab",{"label":17,"type":18,"description":19,"interventionNames":20},"Sintilimab+Chemotherapy","ACTIVE_COMPARATOR","Subjects received sintilimab combined with standard platinum-based doublet chemotherapy for a total of 4 cycles.",[14,15],[22,29,36],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"RADIATION","low-dose radiation therapy and stereotactic body radiation therapy","Patients will receive radiation therapy.",[9],[28],"RT",{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","chemotherapy","Patients will receive sintilimab combined with standard platinum-based doublet chemotherapy for a total of 4 cycles. Patients subsequently received maintenance treatment with sintilimab, and continued treatment until disease progression (PD), intolerable toxicity, withdrawal of informed consent, initiation of other anti-tumor treatments, death, or other circumstances that should stop treatment as specified in the protocol. Whichever occurs first. The maximum treatment time with sintilimab is 24 months (or 35 cycles).",[9,17],[35],"standard platinum-containing double-drug chemotherapy",{"type":30,"name":37,"description":32,"armGroupLabels":38,"otherNames":39},"Sintilimab",[9,17],null,[41],{"name":42,"affiliation":43,"role":44},"You Lu, MD","West China Hospital","PRINCIPAL_INVESTIGATOR",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":39,"email":50},"Jianxin Xue, MD","CONTACT","+86 189 8225 1798","killercell@163.com",{"name":42,"role":48,"phone":52,"phoneExt":39,"email":53},"+86 189 8060 1763","radyoulu@hotmail.com",[55,72,86,95,109,117],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"The Second Affiliated Hospital of Chongqing Medical University","RECRUITING","Chongqing","Chongqing Municipality","400010","China",{"type":63,"coordinates":64},"Point",[65,66],106.55771,29.56026,{"lat":66,"lon":65},[69],{"name":70,"role":48,"phone":39,"phoneExt":39,"email":71},"Zhenzhou Yang","yangzz@cqmu.edu.cn",{"facility":73,"status":57,"city":74,"state":75,"zip":76,"country":61,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Guizhou Provincial People's Hospital","Guiyang","Guizhou","550002",{"type":63,"coordinates":78},[79,80],106.71667,26.58333,{"lat":80,"lon":79},[83],{"name":84,"role":48,"phone":39,"phoneExt":39,"email":85},"Yu Zhang","skyline_zyu@163.com",{"facility":87,"status":57,"city":88,"state":89,"zip":90,"country":61,"cosmosGeoPoint":39,"geoPoint":39,"contacts":91},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","Wuhan","Hunan","430022",[92],{"name":93,"role":48,"phone":39,"phoneExt":39,"email":94},"Rui Meng","mengruivip@163.com",{"facility":96,"status":57,"city":97,"state":98,"zip":99,"country":61,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Sichuan Cancer Hospital","Chengdu","Sichuan","610044",{"type":63,"coordinates":101},[102,103],104.06667,30.66667,{"lat":103,"lon":102},[106],{"name":107,"role":48,"phone":39,"phoneExt":39,"email":108},"Qifeng Wang","wangqifeng@scszlyy.org.cn",{"facility":110,"status":57,"city":97,"state":98,"zip":99,"country":61,"cosmosGeoPoint":111,"geoPoint":113,"contacts":114},"West China Hospital of Sichuan University",{"type":63,"coordinates":112},[102,103],{"lat":103,"lon":102},[115],{"name":116,"role":48,"phone":49,"phoneExt":39,"email":50},"Jianxin Xue",{"facility":118,"status":57,"city":119,"state":98,"zip":120,"country":61,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Affiliated Hospital of North Sichuan Medical College","Nanchong","637503",{"type":63,"coordinates":122},[123,124],106.08473,30.79508,{"lat":124,"lon":123},[127],{"name":128,"role":48,"phone":39,"phoneExt":39,"email":129},"Daiyuan Ma","mdylx@163.com",{"type":44,"investigatorFullName":131,"investigatorTitle":132,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"You Lu","Chair of Division of Thoracic Tumor Multimodality Treatment",[134],{"name":135,"class":136},"Innovent Biologics (Suzhou) Co. Ltd.","INDUSTRY","100525420",false,"NCT06121505","Phase II Trial: Low-Dose Radiation + SBRT + Sintilimab + Chemotherapy vs. Sintilimab + Chemotherapy in Locally Advanced or Metastatic Squamous Cell Lung Cancer","Low-dose Radiation Therapy and Stereotactic Body Radiation Therapy Combined With PD-1 Inhibitor Sintilimab and Chemotherapy Versus PD-1 Inhibitor Combined With Chemotherapy as First-line Treatment for Patients With Locally Advanced or Metastatic Squamous Cell Lung Cancer: A Randomized, Phase II Multicenter Clinical Trial","Inclusion Criteria:\n\n1. Age ≥ 18 years old and ≤ 75 years old;\n2. Histologically or cytologically confirmed squamous cell lung cancer, imaging confirmed locally advanced or metastatic disease (unresectable or not eligible for definitive chemoradiotherapy, stage IIIB-IV);\n3. According to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), there is at least one imaging measurable lesion;\n4. Enough to provide quality control qualified tumor tissue or cell wax blocks to detect PD-L1 expression;\n5. Have not received any systemic anti-tumor treatment for locally advanced or metastatic disease in the past;\n\nExclusion Criteria:\n\n1. The pathology is small cell lung cancer (SCLC), including lung cancer mixed with SCLC and non-small cell lung cancer (NSCLC)；\n2. The pathology is lung adenocarcinoma, including lung cancer mixed with lung adenocarcinoma and lung squamous cell carcinoma;\n3. EGFR gene sensitive mutation or ALK fusion positive or ROS1 fusion positive;\n4. Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or another drug that stimulates or synergistically inhibits T cell receptors;\n5. Pregnant or lactating women;","ALL","18 Years","75 Years",{"count":147,"type":148},114,"ESTIMATED","INTERVENTIONAL",[151],"PHASE2","This is a randomized, controlled, open-label, multicenter phase II clinical trial comparing the efficacy and safety of low-dose radiation therapy and stereotactic body radiation therapy combined with PD-1 inhibitor (sintilimab) and standard platinum-based doublet chemotherapy versus PD-1 inhibitor (sintilimab) combined with standard platinum-based doublet chemotherapy as first-line treatment in patients with locally advanced or metastatic squamous cell lung cancer.\n\nThere will be 57 subjects in the experimental group and 57 subjects in the control group, with a total of 114 subjects.",[154],"Lung Squamous Cell Carcinoma",[156,157,158,154],"SBRT","Immunotherapy","LDRT","2025-12-09",{"date":161,"type":162},"2025-12-17","ACTUAL",{"date":164,"type":162},"2024-03-01",{"date":166,"type":148},"2027-02-28",{"name":5,"class":6},6]