A Prospective, Multicenter, Randomized Controlled Study of Disitamab Vedotin Plus Toripalimab With or Without Pelvic Lymph Node Dissection for Bladder-Sparing Treatment in Patients With cT2-3N0M0 Bladder Urothelial Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- 2-year Bladder-intact Event-free Survival Rate
研究概览
简要总结
This is a prospective, multicenter, randomized controlled superiority study designed to evaluate whether the addition of pelvic lymph node dissection improves bladder-intact event-free survival in patients with cT2-3N0M0 bladder urothelial carcinoma receiving bladder-sparing treatment. Eligible patients with HER2 expression of IHC 2+ or higher who decline radical cystectomy will be randomized 1:1 to receive maximal transurethral resection of bladder tumor followed by disitamab vedotin plus toripalimab with or without standardized pelvic lymph node dissection. The primary endpoint is the 2-year bladder-intact event-free survival rate. Secondary endpoints include clinical complete response, partial response, disease progression, overall survival, quality of life, safety, treatment cost, and exploratory biomarker analyses.
详细描述
Muscle-invasive bladder cancer is commonly treated with radical cystectomy; however, bladder-sparing strategies are needed for selected patients who decline cystectomy. This study evaluates a bladder-sparing strategy based on maximal transurethral resection of bladder tumor, disitamab vedotin plus toripalimab, and the addition of standardized pelvic lymph node dissection.
Participants will be randomized to receive disitamab vedotin plus toripalimab with or without pelvic lymph node dissection after maximal transurethral resection of bladder tumor. Tumor response will be assessed by imaging, cystoscopy or transurethral resection/biopsy when clinically indicated, and urine cytology. Participants who meet bladder-sparing criteria will enter bladder-intact follow-up according to the protocol. Safety, survival, quality of life, treatment cost, and exploratory biomarkers will also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants aged 18 years or older.
- •Histologically confirmed bladder urothelial carcinoma.
- •Clinical stage cT2-3N0M0 according to the AJCC 8th edition TNM staging system.
- •HER2 expression of IHC 2+ or higher.
- •Participants who decline radical cystectomy as assessed by the investigator.
- •Adequate organ function as defined in the study protocol.
- •Ability to understand and willingness to sign written informed consent.
排除标准
- •Known allergy or hypersensitivity to disitamab vedotin, toripalimab, their excipients, or other monoclonal antibodies.
- •Prior radiotherapy for bladder cancer.
- •Prior anticancer treatment that may affect efficacy assessment, as defined in the study protocol.
- •Pregnant or breastfeeding women.
- •Any serious uncontrolled disease or medical condition that, in the investigator's judgment, would make participation inappropriate.
- •Participation in another interventional clinical trial that may interfere with this study.
研究组 & 干预措施
Disitamab Vedotin Plus Toripalimab With Pelvic Lymph Node Dissection
Participants will receive maximal transurethral resection of bladder tumor followed by disitamab vedotin plus toripalimab and standardized pelvic lymph node dissection.
干预措施: Toripalimab (Drug)
Disitamab Vedotin Plus Toripalimab With Pelvic Lymph Node Dissection
Participants will receive maximal transurethral resection of bladder tumor followed by disitamab vedotin plus toripalimab and standardized pelvic lymph node dissection.
干预措施: Disitamab Vedotin (RC48) (Drug)
Disitamab Vedotin Plus Toripalimab With Pelvic Lymph Node Dissection
Participants will receive maximal transurethral resection of bladder tumor followed by disitamab vedotin plus toripalimab and standardized pelvic lymph node dissection.
干预措施: Transurethral Resection of Bladder Tumor (Procedure)
Disitamab Vedotin Plus Toripalimab With Pelvic Lymph Node Dissection
Participants will receive maximal transurethral resection of bladder tumor followed by disitamab vedotin plus toripalimab and standardized pelvic lymph node dissection.
干预措施: Pelvic Lymph Node Dissection (Procedure)
Disitamab Vedotin Plus Toripalimab Without Pelvic Lymph Node Dissection
Participants will receive maximal transurethral resection of bladder tumor followed by disitamab vedotin plus toripalimab without planned pelvic lymph node dissection.
干预措施: Disitamab Vedotin (RC48) (Drug)
Disitamab Vedotin Plus Toripalimab Without Pelvic Lymph Node Dissection
Participants will receive maximal transurethral resection of bladder tumor followed by disitamab vedotin plus toripalimab without planned pelvic lymph node dissection.
干预措施: Transurethral Resection of Bladder Tumor (Procedure)
Disitamab Vedotin Plus Toripalimab Without Pelvic Lymph Node Dissection
Participants will receive maximal transurethral resection of bladder tumor followed by disitamab vedotin plus toripalimab without planned pelvic lymph node dissection.
干预措施: Toripalimab (Drug)
结局指标
主要结局
2-year Bladder-intact Event-free Survival Rate
时间窗: 24 months after randomization
The proportion of participants who remain alive with an intact bladder and without muscle-invasive bladder cancer recurrence, regional lymph node recurrence, distant metastasis, radical cystectomy, or bladder cancer-related death at 24 months after randomization.
次要结局
- Clinical Complete Response Rate(After completion of induction treatment, up to 12 weeks)
- Partial Response Rate(After completion of induction treatment, up to 12 weeks)
- Disease Progression Rate(Up to 24 months after randomization)
- Overall Survival(Up to 60 months after randomization)
- Incidence and Severity of Adverse Events(From the first dose through 30 days after the last dose, up to approximately 19 months)
- Quality of Life Score(Baseline to 24 months after randomization)
- Total Treatment Cost(From randomization to the end of follow-up, up to 60 months)