[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"patient-derived-organoid\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:patient-derived-organoid":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"100568880","pdo-based-drug-sensitive-test-in-rm-sgc-100568880",false,"NCT06686979","PDO Based Drug Sensitive Test in R\u002FM SGC","Consistency Evaluation of Drug Efficacy Between Clinical Systemic Treatment and Drug Sensitive Test Based on Patient-derived Organoid in Patients With Recurrent\u002FMetastatic Salivary Gland Cancer: A Prospective, Multicenter, Observational Study","Inclusion Criteria:\n\n* Pathologically confirmed R\u002FM SGC 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-salivary gland cancer tumors such as sarcoma, squamous cell carcinoma, 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":20,"type":21},40,"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 SGC patients, using a prospective and multicenter observational study to increase the generalizability and reliability of research conclusion.",[26,27,28],"Salivary Gland Cancers","Patient Derived Organoid","Drug Sensitive Test in Vitro",[30,31,32],"Recurrent\u002Fmetastatic salivary gland cancer","Patient-derived organoid","Drug sensitive test in vitro","RECRUITING","2025-08-26",{"date":36,"type":37},"2025-09-03","ACTUAL",{"date":39,"type":37},"2025-03-26",{"date":41,"type":21},"2028-11-30",{"name":43,"class":44},"Huashan Hospital","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":52,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":59,"startDateStruct":60,"completionDateStruct":61,"leadSponsor":63,"locationsCount":5},"100568831","pdo-based-drug-sensitive-test-in-rm-hnscc-100568831","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",{"count":53,"type":21},100,"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.",[56,27,28],"Head and Neck Squamous Cell Carcinoma",[58,31,32],"Recurrent\u002Fmetastatic head and neck squamous cell carcinoma",{"date":36,"type":37},{"date":39,"type":37},{"date":62,"type":21},"2028-11-11",{"name":43,"class":44}]