[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608199":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":26,"responsibleParty":42,"collaborators":26,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":46,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":26,"studyType":58,"phases":59,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":71,"whyStopped":26,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":26},{"fullName":5,"class":6},"Shanghai University of Traditional Chinese Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Gemcitabine Submucosal Injection Arm","EXPERIMENTAL","Patients in this arm will receive submucosal injections of gemcitabine following transurethral resection of bladder tumor (TURBT). The regimen consists of one injection immediately after TURBT, followed by additional injections once every three months, for a total of four injections. Each injection uses 1000mg of gemcitabine. Injection sites are planned based on bladder area and common tumor locations, administered using a specialized injection gun.",[13],"Drug: Gemcitabine Submucosal Injection",{"label":15,"type":16,"description":17,"interventionNames":18},"Gemcitabine Intravesical Instillation Arm","ACTIVE_COMPARATOR","Patients in this arm will receive standard intravesical instillation of gemcitabine following TURBT. The regimen consists of one instillation immediately after surgery, followed by an induction phase of once-weekly instillations for eight weeks, and then a maintenance phase of once-monthly instillations for ten months. Each instillation uses 2000mg of gemcitabine dissolved in 50mL of normal saline, retained for 30-60 minutes.",[19],"Drug: Gemcitabine Intravesical Instillation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Gemcitabine Submucosal Injection","A chemotherapeutic agent. Administered via submucosal injection into the bladder wall using a specialized injection gun. Dosage: 1000mg per injection. Regimen: One injection immediately post-TURBT, followed by one injection every three months for a total of four injections.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Gemcitabine Intravesical Instillation","Standard therapy. Administered by instilling a solution into the bladder via a catheter. Dosage: 2000mg dissolved in 50mL normal saline per instillation. Regimen: One instillation immediately post-TURBT, followed by an induction phase (once weekly for 8 weeks) and a maintenance phase (once monthly for 10 months). The solution is retained for 30-60 minutes.",[15],[32],{"name":33,"affiliation":34,"role":35},"Dongliang Xu","Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Naiwen Chen","CONTACT","+8615858384378","climb2021@163.com",{"type":35,"investigatorFullName":38,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Resident physicians","100608199","phase-2-efficacy-of-gemcitabine-submucosal-injection-for-preventing-recurrence-in-intermediate--and-high-risk-non-muscle-invasive-bladder-cancer-a-randomized-trial-100608199",false,"NCT07198451","Efficacy of Gemcitabine Submucosal Injection for Preventing Recurrence in Intermediate- and High-Risk Non-Muscle-Invasive Bladder Cancer: A Randomized Trial","Efficacy Evaluation of Submucosal Injection of Gemcitabine in Preventing Recurrence of Intermediate- and High-Risk Non-Muscle-Invasive Bladder Cancer: A Randomized, Single-Blind, Multicenter Clinical Study","GEM-IR-NMIBC","Inclusion Criteria:\n\n1. Patients aged 18 to 80 years (inclusive) with radiologically confirmed bladder tumor and scheduled to undergo transurethral resection of bladder tumor (TURBT).\n2. Postoperative pathological confirmation of intermediate- or high-risk non-muscle-invasive bladder cancer (NMIBC).\n3. Voluntarily participate in the study and sign the informed consent form, ensuring the patient fully understands the trial purpose, risks, and right to withdraw.\n\nExclusion Criteria:\n\n1. Preoperative comorbidities including detrusor overactivity, urethral stricture, urge incontinence, stress incontinence, or overflow incontinence.\n2. Concurrent urogenital infectious diseases (e.g., acute urethritis, acute cystitis).\n3. History of pelvic radiotherapy.\n4. Receiving systemic anti-tumor therapy for any malignant tumor.\n5. Severe cardiovascular disease, hepatic or renal insufficiency, or coagulation dysfunction.\n6. Presence of mental illness or psychological disorders that impair normal communication.\n7. Any other situation deemed by the investigator as unsuitable for participation in this clinical study.","ALL","18 Years","80 Years",{"count":56,"type":57},320,"ESTIMATED","INTERVENTIONAL",[60,61],"PHASE2","PHASE3","Bladder cancer is the most common malignant tumor of the urinary system in China, and its incidence has been increasing year by year. It is classified into non-muscle-invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC). NMIBC accounts for 75% of newly diagnosed bladder cancer cases, and transurethral resection of bladder tumor (TURBT) followed by postoperative intravesical therapy is the standard treatment for NMIBC. However, the 5-year recurrence rate of NMIBC remains as high as 50%, with 20-30% of patients progressing to MIBC. MIBC is characterized by rapid progression and a high tendency for metastasis. The 5-year survival rate for patients with metastatic bladder cancer is only 5.4%. This study aims to investigate the efficacy of submucosal injection of the chemotherapeutic agent gemcitabine in preventing recurrence of intermediate- and high-risk NMIBC. Additionally, it seeks to develop software and devices related to submucosal injection to promote the clinical application of this new approach in the chemotherapeutic management of NMIBC. This research is expected to bring a revolutionary breakthrough in the standardisation of whole-process diagnosis and treatment of NMIBC, holding significant scientific value and major clinical translational importance for improving therapeutic outcomes and prognosis of bladder cancer.",[64],"Non Muscle Invasive Bladder Cancer",[66,67,68,69,70],"non muscle invasive bladder cancer","Gemcitabine","Submucosal Injection","Recurrence","Randomized Controlled Trial","NOT_YET_RECRUITING","2025-09-22",{"date":74,"type":75},"2025-09-30","ACTUAL",{"date":77,"type":57},"2025-10",{"date":79,"type":57},"2028-06",{"name":5,"class":6}]