[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562099":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":10,"locations":28,"responsibleParty":64,"collaborators":10,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":10,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":10,"studyType":81,"phases":10,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":31,"whyStopped":10,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Peking University First Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Observation cohort",null,"Patients in the observation group were T3-4 or N+ UTUC patients who were intolerant to chemotherapy or refused chemotherapy after radical surgery. No postoperative treatment was performed, and the patients were regularly rechecked.",[13],"Other: surveillance alone",{"label":15,"type":10,"description":16,"interventionNames":17},"Postoperative immunotherapy+radiotherapy","Adjuvant Immunotherapy: Immunotherapy drug of choice is tirilizumab, which has received national recommendations in metastatic uroepithelial cancer. Tirelizumab 200mg Q3w; the duration of immunotherapy is recommended for at least 1 year.\n\nAdjuvant radiotherapy can be given concurrently or sequentially with adjuvant immunotherapy; it is recommended that radiotherapy can be started within 4-6 weeks after surgery. Rotational intensity-modulated radiotherapy (VMAT), daily image-guided radiotherapy (Daily IGRT) techniques are used.",[18],"Combination Product: Immunotherapy+radiotherapy",[20,24],{"type":21,"name":22,"description":16,"armGroupLabels":23,"otherNames":10},"COMBINATION_PRODUCT","Immunotherapy+radiotherapy",[15],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"surveillance alone","Patients recieve surveillance alone without any adjuvant interventions until any disease progression endpoints occur.",[9],[29,51],{"facility":30,"status":31,"city":32,"state":10,"zip":10,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Departmeng of Urology, Peking University First Hospital","RECRUITING","Beijing","China","CN",{"type":36,"coordinates":37},"Point",[38,39],116.39723,39.9075,{"lat":39,"lon":38},[42,47],{"name":43,"role":44,"phone":45,"phoneExt":10,"email":46},"Xuesong Li, M.D.","CONTACT","+86-15801399116","pineneedle@sina.com",{"name":48,"role":44,"phone":49,"phoneExt":10,"email":50},"Chunru Xu, M.D.","+86-17812172086","xcrbdyy@126.com",{"facility":52,"status":31,"city":32,"state":10,"zip":10,"country":33,"countryCode":34,"cosmosGeoPoint":53,"geoPoint":55,"contacts":56},"Department of Radiotherapy Oncology, Peking University First Hospital",{"type":36,"coordinates":54},[38,39],{"lat":39,"lon":38},[57,61],{"name":58,"role":44,"phone":59,"phoneExt":10,"email":60},"Xianshu Gao, M.D.","+86-13716109164","doctorgaoxs@126.com",{"name":62,"role":44,"phone":59,"phoneExt":10,"email":63},"Xiaoying Li, M.D.","13716109164@139.com",{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","LI xiaoying","Vice Director of the Department of Radiation Oncology","100562099","postoperative-adjuvant-immunotherapy-combined-with-radiotherapy-versus-surgery-alone-in-locally-advanced-utuc-100562099",false,"NCT06598761","Postoperative Adjuvant Immunotherapy Combined with Radiotherapy Versus Surgery Alone in Locally Advanced UTUC","Postoperative Adjuvant Immunotherapy Combined with Radiotherapy Versus Surgery Alone in Locally Advanced Upper Tract Urothelial Carcinoma: a Prospective Observational Cohort Study","Inclusion Criteria:\n\n* 1\\) Patients after radical nephroureterectomy with full-length nephroureterectomy and pathologically confirmed cancer of the renal pelvis or ureter, AJCC staging (8th edition) containing one of the following factors: pT3-4, pN+; 2) Patients with creatinine eGFR \\\u003C60 min\u002FL. or underlying disease refusing to tolerate chemotherapy.\n\n3)18≤age≤80 years old; 4)Completion of abdominopelvic CT 4 weeks prior to enrolment. 5)Except for cutaneous non-melanoma and ductal carcinoma in situ of the breast, the patient has not suffered from any other malignant disease within the last 5 years; 6)Willing to participate in perfecting the necessary examinations and follow-up visits for the sake of the study, and willing to provide written informed consent.\n\nAll of the above need to be fulfilled:\n\nExpected survival \\> 6 months; KPS \\> 70 points; Leukocytes ≥ 3.5 x 109\u002Fl,Neutrophils ≥ 1.5 x 109\u002Fl, Platelets ≥ 100.0 x 109\u002Fl, Haemoglobin ≥ 90g\u002Fl.\n\nExclusion Criteria:\n\n* 1\\) Distant metastases already found at the time of surgery; non-R0 resected patients 2) History of pelvic and abdominal radiotherapy; history of inflammatory bowel disease; history of systemic chemotherapy; (3) Pregnant or breastfeeding women; or women of childbearing potential who are not using reliable contraception; (4) History of malignant tumour (except skin cancer that is not malignant melanoma and cervical cancer in situ, tumours that have been cured for more than 5 years) 5) weight loss \\> 10% within 6 months 6) Presence of active infections in those with pre-existing or co-existing bleeding disorders 7) clinically significant cardiac disease (e.g., hypertension controlled by medication, unstable angina pectoris, New York Heart Association (NYHA) class ≥ II congestive heart failure, unstable symptomatic arrhythmia, or class ≥ II peripheral vascular disease); 8) Psychological, family, and social factors leading to lack of informed consent.","ALL","18 Years","80 Years",{"count":79,"type":80},60,"ESTIMATED","OBSERVATIONAL","This is a prospective cohort study to analyse the safety and efficacy of postoperative adjuvant radiotherapy combined with immunotherapy versus surgery alone group of UTUC patients with T3-4 stages or lymph nodes metastasis(N+) status.",[84,85,86],"Ureter Cancer","Renal Pelvic Carcinoma","Advanced Urothelial Carcinoma",[88,89,90,91,92],"upper tract urothelial carcinoma","Radiotherapy","Immunotherapy","Combined therapy","Prospective cohort study","2024-11-03",{"date":95,"type":96},"2024-11-05","ACTUAL",{"date":98,"type":96},"2022-01-01",{"date":100,"type":80},"2027-08-30",{"name":5,"class":6},2]