NCT07053748尚未招募不适用
Observational Clinical Study on High - Risk NMIBC Patients Choosing Trimodality Bladder - Sparing 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
- OS
研究概览
简要总结
The goal of this observational study is to assess the safety and efficacy of trimodality bladder - sparing therapy in high - risk NMIBC patients. The main questions it aims to answer are:
Is trimodality therapy safe and effective in the short term for high - risk NMIBC patients? What is its long - term effectiveness in terms of EFS, OS, and BI - EFS? How does it affect patients' QOL? Participants will be high - risk NMIBC patients receiving trimodality therapy at Peking University First Hospital. They will be observed to evaluate the therapy's effectiveness and impact on QOL using relevant assessment criteria and QOL scores.
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
- •Histologically confirmed NMIBC (Ta Tis T1).
- •≥2 recurrences after transurethral resection, or lack of response/intolerance to intravesical therapy (e.g., BCG).
- •Refusal of radical cystectomy and choice of TMT for bladder preservation. Aged ≥18 years. Signed informed consent. ECOG performance status of 0-
- •Adequate organ function for chemoradiotherapy:
- •Hematology: Absolute neutrophil count ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥90 g/L.
- •Liver function: Total bilirubin ≤1.5×ULN, ALT and AST ≤2.5×ULN (≤5×ULN if hepatic metastasis is present).
- •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
OS
时间窗: 5 Years
BI-DFS
时间窗: 5 years
DFS
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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