[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562529":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":44,"collaborators":20,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":20,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":20,"overallStatus":67,"whyStopped":20,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Hunan Province Tumor Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"group 1","EXPERIMENTAL","Bronchial endoscopic cryoablation",[13],"Drug: Sintilimab, Nab-Paclitaxel, and Carboplatin",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Sintilimab, Nab-Paclitaxel, and Carboplatin","Cryoablation received at least 2 or more depending on the mass, with 2-3 cycles；Sintilimab 200 mg Q3W plus Nab-Paclitaxel 260mg \u002F m2(Day 1) Q3W + carboplatin AUC 4.25 or 5 (Day 1) Q3W, 4 cycles，until 24 months",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Yongchang Zhang","CONTACT","+8613873123436","zhangyongchang@csu.edu.cn",[28],{"facility":29,"status":20,"city":30,"state":31,"zip":20,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Hunan Cancer hospital","Changsha","Hunan","China","CN",{"type":35,"coordinates":36},"Point",[37,38],112.97087,28.19874,{"lat":38,"lon":37},[41],{"name":42,"role":24,"phone":43,"phoneExt":20,"email":26},"Yongchang Zhang, MD","13873123436",{"type":45,"investigatorFullName":23,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Head of Medical Oncology, Director of Early Clinical Trial Center","100562529","phase-2-bronchoscopic-cryoablation-combined-with-chemo-immunotherapy-in-nsclc-with-central-airway-obstruction-100562529",false,"NCT06604351","Bronchoscopic Cryoablation Combined With Chemo-Immunotherapy in NSCLC With Central Airway Obstruction","The Efficacy and Safety of Bronchoscopic Cryoablation Combined With Sintilimab Plus Platinum-based Chemotherapy as First-line Treatment for Locally Advanced or Metastatic NSCLC With Central Airway Obstruction: A Phase II Study","Example","Inclusion Criteria:\n\n* Understand the requirements and contents of the clinical trial and provide a signed and dated informed consent form.\n* Age≥18 years and≤80 years.\n* Histologically or cytologically confirmed and documented locally advanced or metastatic non-small cell lung cancer (NSCLC) without prior systemic therapy and EGFR-sensitive mutations (19del, L858R and T790M).\n* Presence of a palliative treatment lesion in the central airway that is amenable to ablation, endoscopically assessed to be≥1\u002F3 obstruction, such as primary or metastatic malignancy to the trachea, main bronchi, intermediate bronchi, or segmental bronchi. corresponding respiratory symptoms or obstructive pneumonia is permission to be included.\n* Eastern Cooperative Oncology Group (ECOG) ： 0-2.\n* Predicted survival ≥ 12 weeks.\n* Adequate bone marrow hematopoiesis and organ function (cardiac function, hepatic, and renal function).\n* Presence of measurable lesions according to RECIST 1.1 criteria.\n* Subjects with stable brain metastases may be included in the study.\n\nExclusion Criteria:\n\n* Histological diagnosis of small cell, large cell lung cancer; mixed tumors will be classified based on the primary cell type; if the primary component is small cell, large cell, or neuroendocrine carcinoma, the subject will not be eligible for enrollment; however, mixed adenocarcinoma-squamous cell carcinoma is acceptable. Subjects with driver gene mutations are generally not eligible for enrollment.\n* Malignant central airway obstruction with acute dyspnea or severe life-threatening symptoms of malignant airway stenosis, or assessed by the investigator to be unable to tolerate subsequent treatment; extrinsic airway compression; large pleural effusion, severe coughing, massive hemoptysis, dyspnea, or inability to cooperate; severely impaired lung function with a maximal voluntary ventilation (MVV) \\\u003C 39% or inability to ambulate.\n* Prior systemic therapy for locally or metastatic disease.\n* Uncorrectable coagulation disorders, severe bleeding tendencies, platelet count \\\u003C 50 \\*10\\^9\u002FL, or severe coagulation dysfunction.\n* Presence of symptomatic brain metastases.\n* Known severe hypersensitivity to anti-PD-1 monoclonal antibodies or similar drugs (allergic reactions with CTCAE≥ grade 3 toxicity).\n* Subjects with persistent or active infection, including but not limited to hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV).\n* Any concurrent malignancy other than basal cell carcinoma or cervical carcinoma in situ. (Patients with a history of malignant tumors but with no evidence of disease for≥ 3 years may be included ).\n* Women who are breastfeeding or pregnant.\n* Other conditions assessed by the investigator to be unsuitable for participation in the study.","ALL","18 Years","80 Years",{"count":59,"type":60},39,"ESTIMATED","INTERVENTIONAL",[63],"PHASE2","This study aimed to evaluate the efficacy and safety of bronchoscopic cryoablation combined with sintilimab plus platinum-based chemotherapy as First-line Treatment for locally advanced or metastatic NSCLC with central airway obstruction.",[66],"Non-Small Cell Lung Cancer","NOT_YET_RECRUITING","2024-09-17",{"date":70,"type":71},"2024-09-19","ACTUAL",{"date":73,"type":60},"2024-09-15",{"date":75,"type":60},"2029-05-31",{"name":5,"class":6},1]