An Exploratory Clinical Study of Nimotuzumab in Bladder - Sparing Chemoradiotherapy for Muscle - Invasive Bladder Cancer
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- ORR
研究概览
简要总结
The goal of this exploratory study is to evaluate the safety and efficacy of nimotuzumab combined with chemoradiotherapy in bladder - preserving treatment for MIBC patients who are ineligible for or decline radical cystectomy. The main questions it aims to answer are:
Does nimotuzumab combined with radiotherapy reduce adverse events in elderly bladder cancer patients? Does this combination improve objective response rate (ORR), progression - free survival (PFS), overall survival (OS), and bladder preservation rate in these patients? Participants will be MIBC patients treated with nimotuzumab and chemoradiotherapy, with a planned 5 - year follow - up to assess treatment efficacy and safety.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent. Aged ≥
- •Histologically confirmed urothelial carcinoma of the bladder, staged T2a-T4a, anyN, M0, or recurrent T1 high - grade tumors (7th - edition AJCC staging).
- •Unsuitable or intolerant to cystectomy, or with comorbidities making systemic chemotherapy intolerable, or chemotherapy - averse, or recurrent after prior TURBT and unsuitable for further TURBT or cystectomy.
- •ECOG performance status 0-
- •No severe hematopoietic or major organ dysfunction, or immunodeficiency. Pre - enrollment lab values: white blood cell count ≥3.5×10⁹/L, absolute neutrophil count ≥1.5×10⁹/L, platelets ≥50×10⁹/L, hemoglobin ≥90 g/L; renal: serum creatinine ≤1.2 mg/dL or creatinine clearance ≥60 mL/min; hepatic: total bilirubin ≤3.0×ULN, AST/ALT ≤2.0×ULN; coagulation: INR ≤2.
- •Agreed contraception during the trial for fertile individuals; females of childbearing potential must have a negative pregnancy test within 7 days before initial dosing.
- •No prior chemotherapy, targeted, or immunotherapy for cancer.
排除标准
- •Metastatic cancer. Previous pelvic/abdominal radiotherapy. Uncontrolled infection, intractable epilepsy, high intracranial pressure, hypertension, hyperglycemia, angina (Grade 1/symptomatic/≥Grade 2), peripheral neuropathy, or a history of myocardial infarction/heart failure within 6 months, or jaundice due to hepatic insufficiency.
- •HIV, active hepatitis B (HBsAg and HBV - DNA positive), or active hepatitis C (HCV - RNA positive).
- •Major surgery within 4 weeks before enrollment. Participation in another clinical trial within 4 weeks before enrollment. Other uncontrolled malignancies within the past 5 years (except cervical in - situ carcinoma, squamous cell skin cancer, or localized basal cell carcinoma).
- •Any other researcher - identified reason making participation unsuitable.
研究组 & 干预措施
Nim
干预措施: Nimotuzumab and Radiotherapy (Drug)
结局指标
主要结局
ORR
时间窗: 1 year
PFS
时间窗: 5 years
OS
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