A Prospective, Multicenter, Randomized Controlled Clinical Study Evaluating the Safety and Efficacy of Cryoablation Versus BCG Instillation Therapy for High-risk NMIBC
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 190
- 主要终点
- Tumor residual rate
研究概览
简要总结
This trial plans to enroll 190 eligible patients and randomize them into two groups with a 1:1 ratio, with 95 patients in each group. The experimental group will receive immediate cryoablation therapy at the resection site after TUR, while the control group will only undergo TUR and receive conventional BCG instillation therapy postoperatively. Both groups of subjects will undergo Re-TURBT or cystoscopy 10-12 weeks after surgery to compare the tumor-free residual rates and adverse events between the two groups.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 85, male or female;
- •Preoperatively diagnosed with T1 stage or meeting the criteria for high-risk bladder cancer (accord with the "2023 NCCN Bladder Cancer Guidelines");
- •Good compliance and able to cooperate with observation;
- •Able to understand the purpose of the trial, agree to participate in this study, and have signed the informed consent form.
排除标准
- •Patients with severe infectious diseases such as bacteremia and toxemia;
- •Patients with severe coagulation dysfunction;
- •Patients with severe heart, brain, lung, liver, kidney and other diseases who cannot tolerate surgery;
- •Patients with other concurrent malignancies;
- •Postoperative pathological diagnosis of bladder cancer patients in Tis, Ta, or T2 stages;
- •Preoperative CT/MRI assessment showing tumor invasion beyond the bladder (T3 stage or above);
- •Preoperative assessment indicating distant metastasis or enlarged pelvic lymph nodes;
- •Pregnant or breastfeeding women;
- •Other situations assessed by researchers as unsuitable for inclusion in this study, such as inappropriate anatomical structure, mental or psychological disorders.
研究组 & 干预措施
Cryoablation group
Transurethral resection of bladder tumor, instant cryoablation of the bladder tumor resection site.
干预措施: Transurethral cryoablation (Procedure)
Cryoablation group
Transurethral resection of bladder tumor, instant cryoablation of the bladder tumor resection site.
干预措施: Transurethral resection of bladder tumor (Procedure)
Cryoablation group
Transurethral resection of bladder tumor, instant cryoablation of the bladder tumor resection site.
干预措施: Bcg Intravesical (Drug)
Control group
Transurethral resection of bladder tumor, conventional BCG instillation after surgery
干预措施: Transurethral resection of bladder tumor (Procedure)
Control group
Transurethral resection of bladder tumor, conventional BCG instillation after surgery
干预措施: Bcg Intravesical (Drug)
结局指标
主要结局
Tumor residual rate
时间窗: 10-12 weeks after initial TURBt
10-12 weeks after the initial TUR, Re-TUR or cystoscopy is performed on the original resection site, and a biopsy of the tissue at the original resection site is conducted to analyze and observe whether there is any tumor residue at the original tumor site.
次要结局
- Recurrence(2 years)
- Progression(2 years)