[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597072":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":20,"collaborators":11,"id":24,"slug":25,"hasResults":26,"nctId":27,"briefTitle":28,"officialTitle":28,"acronym":11,"eligibilityCriteria":29,"healthyVolunteers":26,"sex":30,"minAge":31,"maxAge":11,"enrollmentInfo":32,"targetDuration":11,"studyType":35,"phases":36,"briefSummary":38,"conditions":39,"keywords":41,"overallStatus":45,"whyStopped":11,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":11},{"fullName":5,"class":6},"Peking University First Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Nim","EXPERIMENTAL",null,[13],"Drug: Nimotuzumab and Radiotherapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","Nimotuzumab and Radiotherapy","1. nimotuzumab: 200mg, iv, qw, used for 5 weeks.\n2. radiotherapy: radiotherapy is performed according to clinical routine;",[9],{"type":21,"investigatorFullName":22,"investigatorTitle":23,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Shangbin QIN","Doctor","100597072","phase-1-an-exploratory-clinical-study-of-nimotuzumab-in-bladder---sparing-chemoradiotherapy-for-muscle---invasive-bladder-cancer-100597072",false,"NCT07053735","An Exploratory Clinical Study of Nimotuzumab in Bladder - Sparing Chemoradiotherapy for Muscle - Invasive Bladder Cancer","Inclusion Criteria:\n\nSigned informed consent. Aged ≥18. Histologically confirmed urothelial carcinoma of the bladder, staged T2a-T4a, anyN, M0, or recurrent T1 high - grade tumors (7th - edition AJCC staging).\n\nUnsuitable or intolerant to cystectomy, or with comorbidities making systemic chemotherapy intolerable, or chemotherapy - averse, or recurrent after prior TURBT and unsuitable for further TURBT or cystectomy.\n\nECOG performance status 0-2. No severe hematopoietic or major organ dysfunction, or immunodeficiency. Pre - enrollment lab values: white blood cell count ≥3.5×10⁹\u002FL, absolute neutrophil count ≥1.5×10⁹\u002FL, platelets ≥50×10⁹\u002FL, hemoglobin ≥90 g\u002FL; renal: serum creatinine ≤1.2 mg\u002FdL or creatinine clearance ≥60 mL\u002Fmin; hepatic: total bilirubin ≤3.0×ULN, AST\u002FALT ≤2.0×ULN; coagulation: INR ≤2.0.\n\nAgreed contraception during the trial for fertile individuals; females of childbearing potential must have a negative pregnancy test within 7 days before initial dosing.\n\nNo prior chemotherapy, targeted, or immunotherapy for cancer.\n\nExclusion Criteria:\n\nMetastatic cancer. Previous pelvic\u002Fabdominal radiotherapy. Uncontrolled infection, intractable epilepsy, high intracranial pressure, hypertension, hyperglycemia, angina (Grade 1\u002Fsymptomatic\u002F≥Grade 2), peripheral neuropathy, or a history of myocardial infarction\u002Fheart failure within 6 months, or jaundice due to hepatic insufficiency.\n\nHIV, active hepatitis B (HBsAg and HBV - DNA positive), or active hepatitis C (HCV - RNA positive).\n\nMajor surgery within 4 weeks before enrollment. Participation in another clinical trial within 4 weeks before enrollment. Other uncontrolled malignancies within the past 5 years (except cervical in - situ carcinoma, squamous cell skin cancer, or localized basal cell carcinoma).\n\nAny other researcher - identified reason making participation unsuitable.","ALL","18 Years",{"count":33,"type":34},30,"ESTIMATED","INTERVENTIONAL",[37],"PHASE1","The goal of this exploratory study is to evaluate the safety and efficacy of nimotuzumab combined with chemoradiotherapy in bladder - preserving treatment for MIBC patients who are ineligible for or decline radical cystectomy. The main questions it aims to answer are:\n\nDoes nimotuzumab combined with radiotherapy reduce adverse events in elderly bladder cancer patients? Does this combination improve objective response rate (ORR), progression - free survival (PFS), overall survival (OS), and bladder preservation rate in these patients? Participants will be MIBC patients treated with nimotuzumab and chemoradiotherapy, with a planned 5 - year follow - up to assess treatment efficacy and safety.",[40],"Bladder (Urothelial, Transitional Cell) Cancer",[42,43,44],"bladder cancer","TMT","radiation oncology","NOT_YET_RECRUITING","2025-06-27",{"date":48,"type":49},"2025-07-08","ACTUAL",{"date":51,"type":34},"2025-06-30",{"date":53,"type":34},"2027-06-30",{"name":5,"class":6}]