[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562099":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":10,"locations":28,"responsibleParty":63,"collaborators":10,"id":67,"slug":10,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":10,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":10,"studyType":79,"phases":10,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":31,"whyStopped":10,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"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],[29,50],{"facility":30,"status":31,"city":32,"state":10,"zip":10,"country":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Departmeng of Urology, Peking University First Hospital","RECRUITING","Beijing","China",{"type":35,"coordinates":36},"Point",[37,38],116.39723,39.9075,{"lat":38,"lon":37},[41,46],{"name":42,"role":43,"phone":44,"phoneExt":10,"email":45},"Xuesong Li, M.D.","CONTACT","+86-15801399116","pineneedle@sina.com",{"name":47,"role":43,"phone":48,"phoneExt":10,"email":49},"Chunru Xu, M.D.","+86-17812172086","xcrbdyy@126.com",{"facility":51,"status":31,"city":32,"state":10,"zip":10,"country":33,"cosmosGeoPoint":52,"geoPoint":54,"contacts":55},"Department of Radiotherapy Oncology, Peking University First Hospital",{"type":35,"coordinates":53},[37,38],{"lat":38,"lon":37},[56,60],{"name":57,"role":43,"phone":58,"phoneExt":10,"email":59},"Xianshu Gao, M.D.","+86-13716109164","doctorgaoxs@126.com",{"name":61,"role":43,"phone":58,"phoneExt":10,"email":62},"Xiaoying Li, M.D.","13716109164@139.com",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","LI xiaoying","Vice Director of the Department of Radiation Oncology","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":77,"type":78},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.",[82,83,84],"Ureter Cancer","Renal Pelvic Carcinoma","Advanced Urothelial Carcinoma",[86,87,88,89,90],"upper tract urothelial carcinoma","Radiotherapy","Immunotherapy","Combined therapy","Prospective cohort study","2024-11-03",{"date":93,"type":94},"2024-11-05","ACTUAL",{"date":96,"type":94},"2022-01-01",{"date":98,"type":78},"2027-08-30",{"name":5,"class":6},2]