[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646354":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":42,"locations":48,"responsibleParty":372,"collaborators":375,"id":377,"slug":378,"hasResults":379,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":28,"eligibilityCriteria":383,"healthyVolunteers":379,"sex":384,"minAge":385,"maxAge":386,"enrollmentInfo":387,"targetDuration":28,"studyType":390,"phases":391,"briefSummary":393,"conditions":394,"keywords":396,"overallStatus":51,"whyStopped":28,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":410},{"fullName":5,"class":6},"Tongji Hospital","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Arm (RC48 + Gemcitabine)","EXPERIMENTAL","Patients in this arm receive neoadjuvant Disitamab Vedotin (RC48) at a dose of 2.0 mg\u002Fkg via intravenous (IV) infusion (60-90 minutes) on Day 1, followed by Gemcitabine 1000 mg\u002Fm² IV on Day 2. The regimen is administered every 2 weeks (Q2W). Tumor response is evaluated via imaging after 3 cycles. Patients who do not achieve a clinical complete response (cCR) will continue the treatment for an additional 3 cycles (totaling 3 to 6 cycles).",[13,14,15],"Drug: Gemcitabine","Drug: Disitamab Vedotin (RC48)","Procedure: Radical Cystectomy",{"label":17,"type":18,"description":19,"interventionNames":20},"Active Comparator Arm (RC48 + Toripalimab)","ACTIVE_COMPARATOR","Patients in this arm receive neoadjuvant Disitamab Vedotin (RC48) at a dose of 2.0 mg\u002Fkg via IV infusion (60-90 minutes) on Day 1, followed by Toripalimab 3 mg\u002Fkg IV on Day 2. The regimen is administered every 2 weeks (Q2W). Tumor response is evaluated via imaging after 3 cycles, with treatment continuing for a total of 3 to 6 cycles based on the tumor response evaluation.",[21,14,15],"Drug: Toripalimab",[23,29,33,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Gemcitabine","On Day 2 of each neoadjuvant therapy cycle, a dose of 1000 mg\u002Fm² is administered via intravenous infusion. The regimen is administered every 2 weeks (Q2W).",[9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Toripalimab","On Day 2 of each neoadjuvant therapy cycle, a dose of 3 mg\u002Fkg is administered via intravenous infusion. The regimen is administered every 2 weeks (Q2W).",[17],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"Disitamab Vedotin (RC48)","On Day 1 of each neoadjuvant therapy cycle, a dose of 2 mg\u002Fkg is administered via intravenous infusion over 30-60 minutes.",[17,9],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":28},"PROCEDURE","Radical Cystectomy","Patients are scheduled to undergo radical cystectomy (RC) within 4 weeks after the last dose of neoadjuvant therapy, and the postoperative specimens will be assessed for pathological response.",[17,9],[43],{"name":44,"role":45,"phone":46,"phoneExt":28,"email":47},"Zhiquan Hu, M.D.","CONTACT","13971656164","huzhiquan2000@163.com",[49,69,85,99,115,130,145,160,175,190,205,217,231,246,258,273,285,297,309,325,340,355],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"The First Affiliated Hospital of Anhui Medical University","RECRUITING","Hefei","Anhui","230022","China","CN",{"type":58,"coordinates":59},"Point",[60,61],117.28083,31.86389,{"lat":61,"lon":60},[64,67],{"name":65,"role":45,"phone":66,"phoneExt":28,"email":28},"Hanjiang Xu, M.D.","18326170623",{"name":65,"role":68,"phone":28,"phoneExt":28,"email":28},"PRINCIPAL_INVESTIGATOR",{"facility":70,"status":51,"city":71,"state":72,"zip":73,"country":55,"countryCode":56,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Fujian Medical University Union Hospital","Fuzhou","Fujian","350001",{"type":58,"coordinates":75},[76,77],119.30611,26.06139,{"lat":77,"lon":76},[80,84],{"name":81,"role":45,"phone":82,"phoneExt":28,"email":83},"Shaoxing Zhu, M.D.","18758872716","zsxing2005@126.com",{"name":81,"role":68,"phone":28,"phoneExt":28,"email":28},{"facility":86,"status":51,"city":87,"state":72,"zip":88,"country":55,"countryCode":56,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"The First Affiliated Hospital of Xiamen University","Xiamen","361003",{"type":58,"coordinates":90},[91,92],118.08187,24.47979,{"lat":92,"lon":91},[95,98],{"name":96,"role":45,"phone":97,"phoneExt":28,"email":28},"Wei Li, M.D.","13666028912",{"name":96,"role":68,"phone":28,"phoneExt":28,"email":28},{"facility":100,"status":51,"city":101,"state":102,"zip":103,"country":55,"countryCode":56,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Zhujiang Hospital of Southern Medical University","Guangzhou","Guangdong","510280",{"type":58,"coordinates":105},[106,107],113.25,23.11667,{"lat":107,"lon":106},[110,114],{"name":111,"role":45,"phone":112,"phoneExt":28,"email":113},"Abai Xu, M.D.","18665626790","lc96xab@163.com",{"name":111,"role":68,"phone":28,"phoneExt":28,"email":28},{"facility":116,"status":51,"city":117,"state":102,"zip":118,"country":55,"countryCode":56,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center","Shenzhen","518117",{"type":58,"coordinates":120},[121,122],114.0683,22.54554,{"lat":122,"lon":121},[125,129],{"name":126,"role":45,"phone":127,"phoneExt":28,"email":128},"Dongwen Wang, M.D.","13530336918","urology2007@126.com",{"name":126,"role":68,"phone":28,"phoneExt":28,"email":28},{"facility":131,"status":51,"city":132,"state":133,"zip":134,"country":55,"countryCode":56,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture","Enshi","Hubei","445000",{"type":58,"coordinates":136},[137,138],109.48333,30.3,{"lat":138,"lon":137},[141,144],{"name":142,"role":45,"phone":143,"phoneExt":28,"email":28},"Su Chen, M.D.","13477894099",{"name":142,"role":68,"phone":28,"phoneExt":28,"email":28},{"facility":146,"status":51,"city":147,"state":133,"zip":148,"country":55,"countryCode":56,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"Huanggang Central Hospital","Huanggang","438000",{"type":58,"coordinates":150},[151,152],114.87035,30.45143,{"lat":152,"lon":151},[155,159],{"name":156,"role":45,"phone":157,"phoneExt":28,"email":158},"Jiayi Tao, M.D.","13409868766","35149051@qq.com",{"name":156,"role":68,"phone":28,"phoneExt":28,"email":28},{"facility":161,"status":51,"city":162,"state":133,"zip":163,"country":55,"countryCode":56,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Huangshi Central Hospital","Huangshi","435000",{"type":58,"coordinates":165},[166,167],115.04814,30.24706,{"lat":167,"lon":166},[170,174],{"name":171,"role":45,"phone":172,"phoneExt":28,"email":173},"Dingwen Gui, M.D.","13971778131","68661272@qq.com",{"name":171,"role":68,"phone":28,"phoneExt":28,"email":28},{"facility":176,"status":51,"city":177,"state":133,"zip":178,"country":55,"countryCode":56,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"Jingmen Central Hospital","Jingmen","448000",{"type":58,"coordinates":180},[181,182],112.20472,31.03361,{"lat":182,"lon":181},[185,189],{"name":186,"role":45,"phone":187,"phoneExt":28,"email":188},"Zeming Liao, M.D.","13886919765","lzm19731217@qq.com",{"name":186,"role":68,"phone":28,"phoneExt":28,"email":28},{"facility":191,"status":51,"city":192,"state":133,"zip":193,"country":55,"countryCode":56,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"Jingzhou First People's Hospital","Jingzhou","434000",{"type":58,"coordinates":195},[196,197],112.19028,30.35028,{"lat":197,"lon":196},[200,204],{"name":201,"role":45,"phone":202,"phoneExt":28,"email":203},"Haitao Dai, M.D.","18163138773","124316578@qq.com",{"name":201,"role":68,"phone":28,"phoneExt":28,"email":28},{"facility":206,"status":51,"city":192,"state":133,"zip":207,"country":55,"countryCode":56,"cosmosGeoPoint":208,"geoPoint":210,"contacts":211},"Jingzhou Central Hospital","434020",{"type":58,"coordinates":209},[196,197],{"lat":197,"lon":196},[212,216],{"name":213,"role":45,"phone":214,"phoneExt":28,"email":215},"Yixiang Liao, M.D.","18107167675","25261193@qq.com",{"name":213,"role":68,"phone":28,"phoneExt":28,"email":28},{"facility":218,"status":51,"city":219,"state":133,"zip":220,"country":55,"countryCode":56,"cosmosGeoPoint":221,"geoPoint":225,"contacts":226},"Taihe Hospital","Shiyan","442000",{"type":58,"coordinates":222},[223,224],110.77806,32.6475,{"lat":224,"lon":223},[227,230],{"name":228,"role":45,"phone":229,"phoneExt":28,"email":28},"Congbo Chen, M.D.","13907204825",{"name":228,"role":68,"phone":28,"phoneExt":28,"email":28},{"facility":232,"status":51,"city":233,"state":133,"zip":234,"country":55,"countryCode":56,"cosmosGeoPoint":235,"geoPoint":239,"contacts":240},"The Central Hospital of Wuhan","Wuhan","430014",{"type":58,"coordinates":236},[237,238],114.26667,30.58333,{"lat":238,"lon":237},[241,245],{"name":242,"role":45,"phone":243,"phoneExt":28,"email":244},"Yonglian Guo, M.D.","15972152299","15972152299@139.com",{"name":242,"role":68,"phone":28,"phoneExt":28,"email":28},{"facility":247,"status":51,"city":233,"state":133,"zip":248,"country":55,"countryCode":56,"cosmosGeoPoint":249,"geoPoint":251,"contacts":252},"Wuhan No.1 Hospital","430022",{"type":58,"coordinates":250},[237,238],{"lat":238,"lon":237},[253,257],{"name":254,"role":45,"phone":255,"phoneExt":28,"email":256},"Gaofeng Zhou, M.D.","18507134410","910790776@qq.com",{"name":254,"role":68,"phone":28,"phoneExt":28,"email":28},{"facility":259,"status":51,"city":233,"state":133,"zip":260,"country":55,"countryCode":56,"cosmosGeoPoint":261,"geoPoint":263,"contacts":264},"Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology","430030",{"type":58,"coordinates":262},[237,238],{"lat":238,"lon":237},[265,267,268,271],{"name":266,"role":45,"phone":46,"phoneExt":28,"email":47},"Zhiquan Hu",{"name":44,"role":68,"phone":28,"phoneExt":28,"email":28},{"name":269,"role":270,"phone":28,"phoneExt":28,"email":28},"Chunguang Yang, M.D.","SUB_INVESTIGATOR",{"name":272,"role":270,"phone":28,"phoneExt":28,"email":28},"Haijun Huang, M.M.",{"facility":274,"status":51,"city":233,"state":133,"zip":275,"country":55,"countryCode":56,"cosmosGeoPoint":276,"geoPoint":278,"contacts":279},"Renmin Hospital of Wuhan University","430060",{"type":58,"coordinates":277},[237,238],{"lat":238,"lon":237},[280,284],{"name":281,"role":45,"phone":282,"phoneExt":28,"email":283},"Zhiyuan Chen, M.D.","13886000807","chenzhiyuan163@163.com",{"name":281,"role":68,"phone":28,"phoneExt":28,"email":28},{"facility":286,"status":51,"city":233,"state":133,"zip":287,"country":55,"countryCode":56,"cosmosGeoPoint":288,"geoPoint":290,"contacts":291},"Zhongnan Hospital of Wuhan University","430071",{"type":58,"coordinates":289},[237,238],{"lat":238,"lon":237},[292,296],{"name":293,"role":45,"phone":294,"phoneExt":28,"email":295},"Xingyuan Xiao, M.D.","18672923313","xiaoxingyuan@whu.edu.cn",{"name":293,"role":68,"phone":28,"phoneExt":28,"email":28},{"facility":298,"status":51,"city":233,"state":133,"zip":299,"country":55,"countryCode":56,"cosmosGeoPoint":300,"geoPoint":302,"contacts":303},"Hubei Cancer Hospital","430079",{"type":58,"coordinates":301},[237,238],{"lat":238,"lon":237},[304,308],{"name":305,"role":45,"phone":306,"phoneExt":28,"email":307},"Diansheng Cui, M.D.","13871549210","787434798@qq.com",{"name":305,"role":68,"phone":28,"phoneExt":28,"email":28},{"facility":310,"status":51,"city":311,"state":133,"zip":312,"country":55,"countryCode":56,"cosmosGeoPoint":313,"geoPoint":317,"contacts":318},"Xiangyang Central Hospital","Xiangyang","441021",{"type":58,"coordinates":314},[315,316],112.14479,32.0422,{"lat":316,"lon":315},[319,323],{"name":320,"role":45,"phone":321,"phoneExt":28,"email":322},"Bin chen, M.D.","19908671399","625848080@qq.com",{"name":324,"role":68,"phone":28,"phoneExt":28,"email":28},"Bin Chen, M.D.",{"facility":326,"status":51,"city":327,"state":133,"zip":328,"country":55,"countryCode":56,"cosmosGeoPoint":329,"geoPoint":333,"contacts":334},"Yichang Central People's Hospital","Yichang","443003",{"type":58,"coordinates":330},[331,332],111.28472,30.71444,{"lat":332,"lon":331},[335,339],{"name":336,"role":45,"phone":337,"phoneExt":28,"email":338},"Xiaobo Chen, M.D.","13972587419","272899447@qq.com",{"name":336,"role":68,"phone":28,"phoneExt":28,"email":28},{"facility":341,"status":51,"city":342,"state":343,"zip":344,"country":55,"countryCode":56,"cosmosGeoPoint":345,"geoPoint":349,"contacts":350},"Jiangxi Provincial People's Hospital","Nanchang","Jiangxi","330006",{"type":58,"coordinates":346},[347,348],115.85306,28.68396,{"lat":348,"lon":347},[351,354],{"name":352,"role":45,"phone":353,"phoneExt":28,"email":28},"Kehua Jiang, M.D.","18571225053",{"name":352,"role":68,"phone":28,"phoneExt":28,"email":28},{"facility":356,"status":51,"city":357,"state":358,"zip":359,"country":55,"countryCode":56,"cosmosGeoPoint":360,"geoPoint":364,"contacts":365},"Shandong Cancer Hospital and Institute","Jinan","Shandong","250117",{"type":58,"coordinates":361},[362,363],116.99722,36.66833,{"lat":363,"lon":362},[366,370],{"name":367,"role":45,"phone":368,"phoneExt":28,"email":369},"JiaSheng Bian, M.D.","15954104097","sdbjs232466@sina.com",{"name":371,"role":68,"phone":28,"phoneExt":28,"email":28},"Jiasheng Bian, M.D.",{"type":373,"investigatorFullName":266,"investigatorTitle":374,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"SPONSOR_INVESTIGATOR","Clinical professor",[376],{"name":5,"class":6},"100646354","phase-3-neoadjuvant-rc48-plus-gemcitabine-in-her2-expressing-mibc-100646354",false,"NCT07693959","Neoadjuvant RC48 Plus Gemcitabine in HER2-Expressing MIBC","Neoadjuvant RC48 Plus Gemcitabine for HER2 1~3+ MIBC: A Prospective, Multicenter, Randomized, Controlled, Non-inferiority Study (GUARD-02)","Inclusion Criteria:\n\n1. Informed Consent \\& Compliance: Provision of signed informed consent and ability to comply with study procedures and follow-up requirements.\n2. Age: Age 18 to 75 years (inclusive).\n3. Planned Surgery: Planned to undergo radical cystectomy (RC) with lymph node dissection (LND).\n4. Clinical Stage: Clinical stage T2-T4aNxM0, as assessed by CT, MRI, or PET-CT.\n5. Pathology \\& Biomarker: Histologically confirmed predominant urothelial carcinoma by cystoscopic biopsy or transurethral resection of bladder tumor (TURBT), with HER2 expression of 1+ to 3+ determined by immunohistochemistry (IHC).\n6. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.\n7. Adequate Organ Function: Laboratory values meeting the following criteria: Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL; Platelet count ≥ 100 × 10\\^9\u002FL; Hemoglobin ≥ 80 g\u002FL; Total bilirubin ≤ 1.5 × upper limit of normal (ULN); Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 × ULN\n8. Cardiac Function: New York Heart Association (NYHA) class \\\u003C 3.\n9. Reproductive Status \\& Contraception: \\*Female: Must be surgically sterile, postmenopausal, or agree to use highly effective contraception during the study and for 6 months after the last dose of study treatment. Must not be lactating. \\*Male: Must agree to use a medically acceptable method of contraception (e.g., condoms, abstinence) during the study and for 6 months after the last dose of study treatment.\n\nExclusion Criteria：\n\n1. Receipt of live attenuated vaccine within 4 weeks prior to enrollment or planned receipt during the study period.\n2. Receipt of systemic chemotherapy, or anti-PD-1, anti-PD-L1, or HER2-targeted therapy within the past 6 months.\n3. Known hypersensitivity to gemcitabine, disitamab vedotin, toripalimab, or any of their excipients.\n4. Active, known, or suspected autoimmune disease.\n5. Known history of primary immunodeficiency.\n6. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n7. Untreated acute or chronic active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. (Patients receiving continuous antiviral therapy with monitored viral loads may be eligible at the investigator's discretion).\n8. Uncontrolled concurrent illness including, but not limited to: human immunodeficiency virus (HIV) infection, active or poorly controlled severe infection, or evidence of uncontrolled systemic disease (e.g., severe psychiatric\u002Fneurological disorders, decompensated respiratory failure).\n9. History of other malignancies within the past 5 years, excluding clinically cured early-stage tumors.\n10. Active tuberculosis.","ALL","18 Years","75 Years",{"count":388,"type":389},170,"ESTIMATED","INTERVENTIONAL",[392],"PHASE3","Objectives: To evaluate the non-inferiority of disitamab vedotin plus gemcitabine versus disitamab vedotin plus toripalimab in terms of the pathological complete response (pCR) rate as neoadjuvant therapy for muscle-invasive bladder cancer (MIBC).\n\nThis study is designed to evaluate two parallel neoadjuvant treatment strategies followed by definitive local therapy and adjuvant treatment. Eligible patients will be assigned to either the Experimental Arm, receiving neoadjuvant Disitamab Vedotin (RC48) combined with Gemcitabine, or the Active Comparator Arm, receiving neoadjuvant RC48 combined with Toripalimab. Both neoadjuvant regimens are administered every two weeks for 3 to 6 cycles, contingent upon imaging-based tumor response. Following the neoadjuvant phase, patients from both arms will proceed to receive standard Radical Cystectomy (RC) combined with Pelvic Lymph Node Dissection (PLND) within four weeks of their final dose, with a trimodality therapy (TMT) bladder-sparing approach strictly restricted to a selected minority of patients. In the postoperative phase, eligible patients will receive adjuvant therapy consisting of RC48 plus Toripalimab for 6 cycles, followed by Toripalimab maintenance monotherapy for a duration of ≤ 1 year (or a maximum of 1 year).Patients post-RC require abdominopelvic\u002Fchest imaging q3-6m; non-RC patients need cystoscopy q3m and abdominopelvic\u002Fchest CT q3-6m. Follow-up staff should proactively contact patients q3m to record imaging findings and inquire about hematuria, stomal lesions, cough\u002Fchest pain, CNS symptoms, and accurately document recurrence\u002Fprogression, metastasis, death with dates.",[395],"MIBC",[395,397,30,398,25,399,400],"ADC","RC48","Disitamab Vedotin","neoadjuvant therapy","2026-07-06",{"date":403,"type":404},"2026-07-09","ACTUAL",{"date":406,"type":389},"2026-07-01",{"date":408,"type":389},"2029-07-01",{"name":266,"class":6},22]