Evaluation of an Open, Single Arm, Multicenter Phase II Clinical Study on the Neoadjuvant Treatment of HER2 Expressing Myometrial Invasive Bladder Cancer With Disitamab Vedotin for Injection and Gemcitabine
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Pathologic Complete Response
研究概览
简要总结
A multicenter, open, single arm, phase II clinical trial was designed for myometrial invasive bladder cancer to evaluate the efficacy and safety of RC48-ADC combined with gemcitabine in preoperative neoadjuvant treatment of MIBC, and provide high-level clinical evidence for gemcitabine combined with ADC in the treatment of MIBC
详细描述
Patients with myometrial invasive bladder cancer expressing HER2 and not suitable for cisplatin chemotherapy were treated with vedixizumab (RC48) 2.0mg/kg, once every two weeks, intravenous drip (60-90min); Gemcitabine is 1000mg/m2, once every two weeks. After completing 3 cycles of neoadjuvant combined therapy, imaging evaluation was performed. If the tumor is T0, radical surgery for bladder cancer was performed; Otherwise, perform radical surgery for bladder cancer (total cystectomy+standard/extended lymph node dissection) after completing 1-3 cycles of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects voluntarily joined the study, signed the informed consent form, and were able to follow the study and follow-up procedures
- •Suitable and planned for radical cystectomy (including lymph node dissection)
- •Clinical stage T2-T4aN0M0 (CT/MR/PET-CT evaluation)
- •Pathologically, it is urothelial carcinoma, and the patient has HER2 expression and refuses neoadjuvant chemotherapy or physical condition/renal function [glomerular filtration rate (GFR) 30-60mL/min], which is not suitable for neoadjuvant chemotherapy (pathology allows urothelial carcinoma to merge with other variant subtypes, with urothelial carcinoma as the main type)
- •ECOG score 0 or 1
- •There is residual tumor after TURBT (cystoscopy or imaging evidence)
- •The blood test of subjects should meet the following requirements
排除标准
- •Receive live attenuated vaccine within 4 weeks before enrollment or during the study period.
- •Have received systemic chemotherapy and targeted therapy of anti-PD-1, PD-L1 and HER2 in the past 6 months
- •Known allergy to gemcitabine/RC48 and its components
- •Active, known or suspected autoimmune diseases.
- •A history of primary immunodeficiency is known.
研究组 & 干预措施
Vidiximab and Gemcitabine Neoadjuvant therapy
Vidiximab (RC48) 2.0mg/kg, once every two weeks, intravenous drip (60-90 min); Gemcitabine is 1000mg/m2, once every 2 weeks
干预措施: Disitamab Vedotin and Gemcitabine (Drug)
结局指标
主要结局
Pathologic Complete Response
时间窗: three years
Neoadjuvant therapy and postoperative pathology confirmed that the primary tumor was in complete remission (stage ypT0) and had no residual tumor cells, regardless of whether the regional lymph nodes were involved or not.
次要结局
未报告次要终点
研究者
Chunguang yang (101937)
Professor
Tongji Hospital