[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567861":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":34,"responsibleParty":63,"collaborators":22,"id":67,"slug":22,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":22,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":52,"whyStopped":22,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SBRT combined with PD-1","EXPERIMENTAL","Week 1: SBRT radiation therapy administered as 24Gy\u002F3f, on days 1, 3, and 5. Weeks 2-5: Tislelizumab 200mg intravenous drip every 3 weeks, for a total of two cycles.",[13],"Drug: Tislelizumab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Tislelizumab","SBRT",[9],[21],"Radiotherapy",null,[24,30],{"name":25,"role":26,"phone":27,"phoneExt":28,"email":29},"Chun-Yan Chen","CONTACT","13826423812","86","chenchuny@sysucc.org.cn",{"name":31,"role":26,"phone":32,"phoneExt":28,"email":33},"Ya-Ni Zhang","15914271501","zhangyn1@sysucc.org.cn",[35,51],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Sun Yat-sen University Cancer Center","NOT_YET_RECRUITING","Guangzhou","Guangdong","510060","China",{"type":43,"coordinates":44},"Point",[45,46],113.25,23.11667,{"lat":46,"lon":45},[49],{"name":50,"role":26,"phone":27,"phoneExt":28,"email":29},"Chun-Yan Chen, MD",{"facility":36,"status":52,"city":38,"state":39,"zip":40,"country":41,"cosmosGeoPoint":53,"geoPoint":55,"contacts":56},"RECRUITING",{"type":43,"coordinates":54},[45,46],{"lat":46,"lon":45},[57,60],{"name":58,"role":26,"phone":59,"phoneExt":22,"email":29},"Chun-Yan Chen, Prof.","020-87341779",{"name":61,"role":26,"phone":62,"phoneExt":22,"email":33},"Ya-Ni Zhang, Dr.","02087342925",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Chen Chunyan","Prof.","100567861",false,"NCT06673693","Tislelizumab Combined With SBRT for the Treatment of Head and Neck Squamous Cell Carcinoma","Neoadjuvant SBRT Sequential Tislelizumab in Locally Advanced Head and Neck Squamous Cell Carcinoma: A Single-Arm Phase II Clinical Study","NEOSTART","Inclusion Criteria:\n\n* Pathologically confirmed, initially treated, surgically resectable head and neck squamous cell carcinoma.\n* Clinical stage III to IVB (AJCC 8th edition), except HPV-positive oropharyngeal cancer\n* Following multidisciplinary discussions involving otolaryngologists and radiation oncologists, the assessment concluded that the tumor is resectable or marginally resectable and suitable for preoperative SBRT\n* Karnofsky Performance Status score ≥ 70\n* Ages 18 to 70\n* The primary organ functions meet the test requirements\n* Patients participate voluntarily and sign informed consent forms\n\nExclusion Criteria:\n\n* Patients previously treated with head and neck surgery were excluded from diagnostic biopsies of primary and regional lymph nodes\n* Previous chemotherapy for any reason, or radiotherapy in the head and neck area, or molecular targeted drug therapy; Previously received anti-PD-1, anti-PD-L1, anti-PD-L2 and other drugs or drugs acting on another irritating or co-inhibitory T cell receptor (such as CTLA-4, OX 40, CD137) treatment, or cell biotherapy\n* Pregnant or lactating women\n* Have had or co-had other malignancies\n* The patient also has a serious, uncontrolled illness\n* Heart, brain, lung and other important organ function abnormal. Patients with hypertension (systolic blood pressure \\>140 mmHg, diastolic blood pressure \\>90 mmHg) who cannot be reduced to the normal range by antihypertensive drugs have grade I or above myocardial ischemia or myocardial infarction, arrhythmia, and grade II cardiac insufficiency; Abnormal coagulation function (INR \\>1.5 or prothrombin time (PT) \\> ULN+4 seconds or APTT \\>1.5 ULN), have a tendency to bleed or are receiving thrombolytic or anticoagulant therapy; Have a definite bleeding tendency; Patients with positive urinary protein (urinary protein test 2+ or more, or 24-hour urinary protein quantification \\>1.0g)\n* Glucocorticoid therapy for 30 days prior to initial administration (prednisone equivalent dose \\> 10mg daily); Have an active autoimmune disease that has required systemic treatment (i.e., disease-modulating drugs, corticosteroids, or immunosuppressive drugs) in the last 2 years\n* History of non-infectious pneumonia requiring corticosteroid treatment within 1 year prior to the first dose administration or current presence of interstitial lung disease\n* Active infections such as tuberculosis that require systemic treatment\n* A known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1\u002F2 antibody positive)\n* Untreated active hepatitis B; Note: Hepatitis B subjects who met the following criteria were also eligible for inclusion: HBV viral load must be \\\u003C1000 copies \u002Fml (200 IU\u002Fml) prior to initial dosing, and subjects should receive anti-HBV therapy to avoid viral reactivation throughout study chemotherapeutic therapy. Subjects with anti-HBC (+), HBsAg (-), anti-HBS (-) and HBV viral load (-) do not need to receive prophylactic anti-HBV therapy, but need to closely monitor viral reactivation. Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection)\n* Patients who have a history of psychotropic substance abuse and cannot abstain or have mental disorders\n* The investigator determines other circumstances that may affect the conduct of the clinical study and the determination of the study results\n* While participating in another therapeutic clinical study","ALL","18 Years","70 Years",{"count":78,"type":79},24,"ESTIMATED","INTERVENTIONAL",[82],"PHASE2","Exploring the efficacy and safety of Tislelizumab combined with stereotactic body radiation therapy (SBRT) as neoadjuvant treatment for locally advanced head and neck squamous cell carcinoma (HNSCC).",[85,86],"Head and Neck Squamous Cell Carcinoma (HNSCC)","HNSCC",[18,88,17,89],"PD-1 antibody","Neoadjuvant Therapy","2025-04-13",{"date":92,"type":93},"2025-04-16","ACTUAL",{"date":95,"type":79},"2025-04-15",{"date":97,"type":79},"2029-12-31",{"name":5,"class":6},2]