一分钟看懂
这是一项关于尿路上皮癌的I 期研究，登记的药物或干预包括Disitamab Vedotin；Toripalimab；Cetirizine；Mecobalamin，当前状态为尚未开始招募。登记地点显示中国广州有研究中心记录。是否仍有名额以及是否值得进一步询问，需要向研究中心确认。
药物或干预
Disitamab Vedotin；Toripalimab；Cetirizine；Mecobalamin · I 期
登记条件中文摘要
年龄范围：18岁及以上
登记的基本范围为不限性别，年龄18岁及以上；以下仅摘录8项专业入选条件，需结合英文原文并由研究团队确认。
登记记录列出8项主要排除条件，具体医学含义需结合英文原文并由研究团队确认。
中国哪些地方有记录
以下地点来自登记信息，不代表此刻仍有名额；请向研究中心确认最新情况。
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University · 广州
入选条件原文摘录
以下为摘录，请打开原始登记查看完整入排标准。
- 1. Voluntarily agrees to participate in the study, is able to provide written informed consent, and is able to understand and comply with the study requirements and assessment schedule.
- 2. Age ≥18 years, regardless of sex.
- 3. Histologically or cytologically confirmed bladder urothelial carcinoma, including pure urothelial carcinoma or mixed bladder carcinoma with a predominant urothelial carcinoma component (≥50%), with clinically diagnosed unresectable locally advanced, recurrent, or metastatic disease that is not suitable for curative surgery or definitive radiotherapy.
- 4. HER2 expression ≥1+ by immunohistochemistry, as determined at the local laboratory using a pretreatment tumor specimen.
- 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- 6. Adequate organ function, as demonstrated by the following laboratory values obtained within 14 days before enrollment:
- a. The following hematologic criteria must be met without growth factor support within 14 days before sample collection: i. Absolute neutrophil count ≥1.5 × 10\^9/L; ii. Platelet count ≥90 × 10\^9/L; iii. Hemoglobin ≥90 g/L. b. International normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤1.5 × the upper limit of normal (ULN).
- c. Total serum bilirubin ≤1.5 × ULN; for participants with Gilbert syndrome or predominantly indirect hyperbilirubinemia of extrahepatic origin, total bilirubin must be ≤3 × ULN.
联系前需要确认
请继续确认中心是否启动、疾病分型、既往治疗、检查费用和知情同意安排。
查看登记信息
登记号：NCT07853053；登记信息更新于 2026-10-01；本站同步于 2026-10-08，中国中心当前名额未经人工确认。