[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525420":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":40,"centralContacts":45,"locations":54,"responsibleParty":131,"collaborators":134,"id":138,"slug":139,"hasResults":140,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":39,"eligibilityCriteria":144,"healthyVolunteers":140,"sex":145,"minAge":146,"maxAge":147,"enrollmentInfo":148,"targetDuration":39,"studyType":151,"phases":152,"briefSummary":154,"conditions":155,"keywords":157,"overallStatus":57,"whyStopped":39,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},{"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",[55,73,87,96,110,118],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"The Second Affiliated Hospital of Chongqing Medical University","RECRUITING","Chongqing","Chongqing Municipality","400010","China","CN",{"type":64,"coordinates":65},"Point",[66,67],106.55771,29.56026,{"lat":67,"lon":66},[70],{"name":71,"role":48,"phone":39,"phoneExt":39,"email":72},"Zhenzhou Yang","yangzz@cqmu.edu.cn",{"facility":74,"status":57,"city":75,"state":76,"zip":77,"country":61,"countryCode":62,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Guizhou Provincial People's Hospital","Guiyang","Guizhou","550002",{"type":64,"coordinates":79},[80,81],106.71667,26.58333,{"lat":81,"lon":80},[84],{"name":85,"role":48,"phone":39,"phoneExt":39,"email":86},"Yu Zhang","skyline_zyu@163.com",{"facility":88,"status":57,"city":89,"state":90,"zip":91,"country":61,"countryCode":62,"cosmosGeoPoint":39,"geoPoint":39,"contacts":92},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","Wuhan","Hunan","430022",[93],{"name":94,"role":48,"phone":39,"phoneExt":39,"email":95},"Rui Meng","mengruivip@163.com",{"facility":97,"status":57,"city":98,"state":99,"zip":100,"country":61,"countryCode":62,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Sichuan Cancer Hospital","Chengdu","Sichuan","610044",{"type":64,"coordinates":102},[103,104],104.06667,30.66667,{"lat":104,"lon":103},[107],{"name":108,"role":48,"phone":39,"phoneExt":39,"email":109},"Qifeng Wang","wangqifeng@scszlyy.org.cn",{"facility":111,"status":57,"city":98,"state":99,"zip":100,"country":61,"countryCode":62,"cosmosGeoPoint":112,"geoPoint":114,"contacts":115},"West China Hospital of Sichuan University",{"type":64,"coordinates":113},[103,104],{"lat":104,"lon":103},[116],{"name":117,"role":48,"phone":49,"phoneExt":39,"email":50},"Jianxin Xue",{"facility":119,"status":57,"city":120,"state":99,"zip":121,"country":61,"countryCode":62,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Affiliated Hospital of North Sichuan Medical College","Nanchong","637503",{"type":64,"coordinates":123},[124,125],106.08473,30.79508,{"lat":125,"lon":124},[128],{"name":129,"role":48,"phone":39,"phoneExt":39,"email":130},"Daiyuan Ma","mdylx@163.com",{"type":44,"investigatorFullName":132,"investigatorTitle":133,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"You Lu","Chair of Division of Thoracic Tumor Multimodality Treatment",[135],{"name":136,"class":137},"Innovent Biologics (Suzhou) Co. Ltd.","INDUSTRY","100525420","phase-2-phase-ii-trial-low-dose-radiation--sbrt--sintilimab--chemotherapy-vs-sintilimab--chemotherapy-in-locally-advanced-or-metastatic-squamous-cell-lung-cancer-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":149,"type":150},114,"ESTIMATED","INTERVENTIONAL",[153],"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.",[156],"Lung Squamous Cell Carcinoma",[158,159,160,156],"SBRT","Immunotherapy","LDRT","2025-12-09",{"date":163,"type":164},"2025-12-17","ACTUAL",{"date":166,"type":164},"2024-03-01",{"date":168,"type":150},"2027-02-28",{"name":5,"class":6},6]