[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Zhiquan Hu\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":73},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100650046","phase-2-neoadjuvant-gemcitabine-plus-trastuzumab-rezetecan-in-her2-positive-utuc-100650046",false,"NCT07741448","Neoadjuvant Gemcitabine Plus Trastuzumab Rezetecan in HER2-positive UTUC","An Open-label, Single-arm, Multicenter Phase II Clinical Study to Evaluate Neoadjuvant Gemcitabine Combined With Trastuzumab Rezetecan in HER2-positive Upper Tract Urothelial Carcinoma","Inclusion Criteria:\n\n1. The subject voluntarily participates in the study, provides written informed consent, and is able to comply with study procedures and follow-up visits.\n2. Aged between 18 and 75 years.\n3. Patients diagnosed with upper tract urothelial carcinoma (UTUC) who are candidates for radical nephroureterectomy with bladder cuff excision.\n4. Clinical stage T1N0M0 - T2-T4aN1M0 (evaluated by CT\u002FMRI\u002FPET-CT).\n5. Histopathology confirms urothelial carcinoma as the predominant component; IHC testing shows HER2 expression of 2+ to 3+.\n6. ECOG performance status ≤ 2.\n7. Laboratory parameters meet all of the following criteria:\n\n   * Absolute neutrophil count ≥ 1.5 × 10⁹\u002FL\n   * Platelets ≥ 100 × 10⁹\u002FL; hemoglobin ≥ 90 g\u002FL\n   * Total bilirubin ≤ 1.5 × ULN\n   * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) ≤ 2.5 × ULN; serum creatinine ≤ 3 × ULN\n8. Cardiac function: New York Heart Association (NYHA) classification \\\u003C Grade III.\n\nExclusion Criteria:\n\n1. Received live attenuated vaccines within 4 weeks prior to enrollment or plan to receive such vaccines during the study.\n2. Received systemic chemotherapy, anti-PD-1\u002FPD-L1 agents, or HER2-targeted therapy within the previous 6 months.\n3. Known hypersensitivity to gemcitabine, Trastuzumab Rezetecan, or any of their excipients.\n4. Active, known or suspected autoimmune disease.\n5. Known history of primary immunodeficiency.\n6. Known history of solid organ allotransplantation or allogeneic hematopoietic stem cell transplantation.\n7. Female patients who are pregnant or breastfeeding.\n8. Untreated acute or chronically active hepatitis B or hepatitis C infection. Patients receiving antiviral therapy may be considered eligible at the investigator's discretion with ongoing viral load monitoring.\n9. Uncontrolled concurrent illnesses, including but not limited to:\n\n   1. HIV infection (positive HIV antibody).\n   2. Severe active infection with inadequate clinical control.\n   3. Evidence of severe or uncontrolled systemic disease (e.g., severe psychiatric or neurological disorders, epilepsy or dementia; unstable or decompensated respiratory, cardiovascular, hepatic or renal disease; uncontrolled hypertension defined as CTCAE Grade ≥2 hypertension despite medical treatment).\n10. Active bleeding, newly diagnosed thromboembolic disease requiring therapeutic anticoagulation, or bleeding diathesis.\n11. Diagnosis of another malignant tumor within the past 5 years.\n12. Active tuberculosis","ALL","18 Years","75 Years",{"count":20,"type":21},54,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Upper tract urothelial carcinoma (UTUC) carries a poor prognosis, with conventional GC (gemcitabine plus cisplatin) regimens achieving only a 19% pathological complete response (pCR) rate in the neoadjuvant setting. Antibody-drug conjugates (ADCs) have shown promising results in advanced urothelial carcinoma, Meanwhile the clinical application of traditional cisplatin-based chemotherapy is associated with significant limitations. Therefore, exploring the efficacy and safety of Trastuzumab Rezetecan (an anti-HER2 ADC) combined with gemcitabine in UTUC is of considerable importance.\n\nThis trial will enroll patients with HER2 2-3+ UTUC. After pathological diagnosis, patients will receive intravenous infusions of gemcitabine and Trastuzumab Rezetecan. The treatment regimen consists of a 21-day cycle: 4 cycles of neoadjuvant therapy, followed by 2 cycles of adjuvant therapy for patients who do not achieve pCR (total of 6 cycles). For patients with suboptimal pathological downstaging after surgery (≥ypT3 or ypN+), combination with immune checkpoint inhibitors (ICIs) is recommended.\n\nDuring the neoadjuvant period, adverse events will be closely monitored. Regular imaging and follow-up assessments will be performed, and events such as disease recurrence, progression, and their corresponding time points will be documented.\n\nThe primary endpoint is pCR rate. Secondary endpoints include adverse events during the neoadjuvant period, event-free survival (EFS), overall survival (OS).",[27],"UTUC",[29,30,27,31],"Trastuzumab Rezetecan","Gemcitabine","neoadjuvant therapy","RECRUITING","2026-07-29",{"date":35,"type":36},"2026-08-03","ACTUAL",{"date":38,"type":21},"2026-08-15",{"date":40,"type":21},"2029-08-15",{"name":42,"class":43},"Zhiquan Hu","OTHER",10,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100646354","phase-3-neoadjuvant-rc48-plus-gemcitabine-in-her2-expressing-mibc-100646354","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.",{"count":53,"type":21},170,[55],"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.",[58],"MIBC",[58,60,61,62,30,63,31],"ADC","Toripalimab","RC48","Disitamab Vedotin","2026-07-06",{"date":66,"type":36},"2026-07-09",{"date":68,"type":21},"2026-07-01",{"date":70,"type":21},"2029-07-01",{"name":42,"class":43},22,""]