NCT07053722尚未招募不适用
Observational Clinical Study of Patients With Muscle - Invasive Bladder Cancer Undergoing Bladder Preservation Therapy After Neoadjuvant Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- DFS
研究概览
简要总结
The goal of this observational study is to evaluate the safety and efficacy of neoadjuvant therapy followed by bladder - preserving TMT in patients with MIBC. The main question it aims to answer is: Does this treatment model improve long - term outcomes, including survival, local control, distant metastasis, and bladder preservation rates? Participants who received neoadjuvant therapy and underwent TMT for bladder preservation will be observed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Histopathologically confirmed bladder cancer (T2-T4aN0-2M0, 8th edition AJCC staging).
- •Underwent bladder - sparing TMT following neoadjuvant therapy (ADC, immunotherapy, or chemotherapy).
- •Aged ≥18 years. Signed an informed consent form. Good general condition with ECOG performance status of 0-
- •Adequate organ function for chemoradiotherapy: (1) Hematology: Absolute neutrophil count ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥90 g/L. (2) Liver function: Total bilirubin ≤1.5×ULN, ALT and AST ≤2.5×ULN (≤5×ULN if hepatic metastasis is present). (3) Renal function: Creatinine clearance ≥30 mL/min (via Cockcroft-Gault formula).
排除标准
- •Distant metastasis (M1). Other malignancies (except cured basal cell carcinoma or cervical carcinoma in situ).
- •Severe cardiovascular disease (uncontrolled heart failure, unstable angina, myocardial infarction, etc.).
- •Severe hepatic/renal dysfunction intolerance to chemoradiotherapy. Mental illness/cognitive impairment unable to comply with the study. Allergy to chemoradiotherapy drugs. Pregnant or breastfeeding women. Previous pelvic radiotherapy.
结局指标
主要结局
DFS
时间窗: 5 years
OS
时间窗: 5 years
BI - EFS
时间窗: 5 years
次要结局
未报告次要终点
研究者
Shangbin QIN
Doctor
Peking University First Hospital
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