[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568831":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":23,"centralContacts":27,"locations":37,"responsibleParty":60,"collaborators":63,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":10,"eligibilityCriteria":102,"healthyVolunteers":98,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":109,"studyType":110,"phases":10,"briefSummary":111,"conditions":112,"keywords":116,"overallStatus":53,"whyStopped":10,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Huashan Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Observational cohort",null,"The observational group of patients with R\u002FM HNSCC would receive drug treatment according to the clinical guideline or doctor's experience. No intervention would be provided based on the drug sensitive test from patient-derived organoid.",[13,14],"Other: No intervention","Other: No Intervention: Observational Cohort",[16,20],{"type":6,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"No intervention","The patients with R\u002FM HNSCC would receive drug treatment according to the clinical guideline or doctor's experience, at the same time, tumor biopsy samples would be collected to establish PDO for drug sensitive test. But no intervention would be used based on the PDO drug sensitive test.",[9],{"type":6,"name":21,"description":18,"armGroupLabels":22,"otherNames":10},"No Intervention: Observational Cohort",[9],[24],{"name":25,"affiliation":5,"role":26},"Lai-ping Zhong, MD, PhD","PRINCIPAL_INVESTIGATOR",[28,32],{"name":25,"role":29,"phone":30,"phoneExt":10,"email":31},"CONTACT","+862152888915","zhonglp@hotmail.com",{"name":33,"role":29,"phone":34,"phoneExt":35,"email":36},"Tong-chao Zhao, MD, PhD","+862152889999","7182","961497591@qq.com",[38,52],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":10},"Huashan Hospital, Fudan University","ACTIVE_NOT_RECRUITING","Shanghai","Shanghai Municipality","200040","China","CN",{"type":47,"coordinates":48},"Point",[49,50],121.45806,31.22222,{"lat":50,"lon":49},{"facility":39,"status":53,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":54,"geoPoint":56,"contacts":57},"RECRUITING",{"type":47,"coordinates":55},[49,50],{"lat":50,"lon":49},[58,59],{"name":25,"role":29,"phone":30,"phoneExt":10,"email":31},{"name":33,"role":29,"phone":34,"phoneExt":35,"email":36},{"type":26,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Lai-ping Zhong","Professor",[64,66,68,70,72,74,77,79,81,83,85,87,89,91,93],{"name":65,"class":6},"Shanghai Cancer Hospital, China",{"name":67,"class":6},"Eye & ENT Hospital of Fudan University",{"name":69,"class":6},"Dongfang Hospital Affiliated to Tongji University",{"name":71,"class":6},"Shandong Cancer Hospital and Institute",{"name":73,"class":6},"Qilu Hospital of Shandong University",{"name":75,"class":76},"Shandong Provincial Hospital","OTHER_GOV",{"name":78,"class":6},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"name":80,"class":6},"Tongji Hospital",{"name":82,"class":6},"Hospital of Stomatology, Wuhan University",{"name":84,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"name":86,"class":6},"First Affiliated Hospital of Zhejiang University",{"name":88,"class":6},"Sir Run Run Shaw Hospital",{"name":90,"class":6},"Zhejiang Cancer Hospital",{"name":92,"class":6},"Shanghai Zhongshan Hospital",{"name":94,"class":95},"Shanghai Huangpu District Central Hospital","UNKNOWN","100568831","pdo-based-drug-sensitive-test-in-rm-hnscc-100568831",false,"NCT06686342","PDO Based Drug Sensitive Test in R\u002FM HNSCC","Consistency Evaluation of Drug Efficacy Between Clinical Systemic Treatment and Drug Sensitive Test Based on Patient-derived Organoid in Patients With Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma: A Prospective, Multicenter, Observational Study","Inclusion Criteria:\n\n* Pathologically confirmed R\u002FM HNSCC patients\n* Tumor tissues available for organoid culture\n* ECOG score: 0-2 points\n* Life expectancy \\> 3 months\n* Normal major organ function, tolerable to chemotherapy, targeted therapy, immunotherapy: a. Hematology examination criteria must meet: WBC≥4.0×109\u002FL, ANC≥1.5×109\u002FL, PLT≥80×109\u002FL, Hb≥90 g\u002FL (no blood transfusion or blood products within 14 days, no use of G-CSF or other hematopoietic growth factors); b. Biochemical examination must meet the following criteria: serum albumin≥3.0 g\u002FdL (30 g\u002FL), TBIL≤1.5×ULN, ALT, AST≤2.5×ULN, BUN and CRE≤1.5×ULN or endogenous creatinine clearance≥60 ml\u002Fmin (Cockcroft-Gault formula); c. Good coagulation function: defined as International Normalized Ratio (INR) or Prothrombin Time (PT)≤1.5 times ULN; if the study participant is on anticoagulant therapy, as long as PT is within the intended range of the anticoagulant medication\n* Able to understand the content of informed consent form, sign the informed consent form, and willing to cooperate with the follow-up\n\nExclusion Criteria:\n\n* Metastatic tumors in the head and neck region, or non-HNSCC such as sarcoma, adenocarcinoma, nasopharyngeal carcinoma, etc.\n* Known allergy to the study drugs or their active ingredients or any excipients; or had a severe allergic reaction to other monoclonal antibodies\n* Pregnant or breastfeeding female patients; or women of childbearing age with positive pregnancy test results (serum or urine) within 7 days before enrollment, or negative results but refusing to use effective contraception during the study period and 2 months after the last administration of study medication; or male patients with partners of childbearing age, refusing to use effective contraception during the study period and 2 months after the last administration of study medication\n* Severe liver diseases (such as cirrhosis), kidney diseases, respiratory system diseases, hematopoietic system diseases, or endocrine system diseases, uncontrolled diseases\n* Infected with HIV, active hepatitis B (HBV-DNA≥104 copies\u002Fml) or hepatitis C (hepatitis C antibody positive, and HCR-RNA above the lower limit of detection of the analytical method), uncontrolled diseases\n* Within 6 months before enrollment, the following conditions occurred: myocardial infarction, severe\u002Funstable angina, NYHA class 2 or above heart failure, clinically significant supraventricular or ventricular arrhythmias, and symptomatic congestive heart failure, uncontrolled diseases\n* Patients with mental illness or known history of psychiatric drug abuse or drug addiction\n* Unable to give consent, unable to obtain the required amount of tumor tissue for the study\n* Other serious physical or mental diseases or laboratory test abnormalities that may increase the risk of participating in the study or interfere with the study results; or any other situation that the researchers deem unsuitable for participation in this study","ALL","18 Years","80 Years",{"count":107,"type":108},100,"ESTIMATED","2 Years","OBSERVATIONAL","To evaluate the consistency of drug efficacy between the clinical systemic treatment and drug sensitive test based on patient-derived organoid in R\u002FM HNSCC patients, using a prospective and multicenter observational study to increase the generalizability and reliability of research conclusion.",[113,114,115],"Head and Neck Squamous Cell Carcinoma","Patient Derived Organoid","Drug Sensitive Test in Vitro",[117,118,119],"Recurrent\u002Fmetastatic head and neck squamous cell carcinoma","Patient-derived organoid","Drug sensitive test in vitro","2025-08-26",{"date":122,"type":123},"2025-09-03","ACTUAL",{"date":125,"type":123},"2025-03-26",{"date":127,"type":108},"2028-11-11",{"name":5,"class":6},2]