Efficacy of Atezolizumab Concurrent With Radiotherapy in Patients With Muscle-invasive Bladder cáncer (Study ATEZOBLADDERPRESERVE)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 39
- 试验地点
- 10
- 主要终点
- Pathological complete response
研究概览
简要总结
Open, multicentre, phase II trial of atezolizumab with concurrent normofractionated radiotherapy in patients with localized muscle-invasive bladder cancer treated with a selective multimodality bladder conservative approach.
详细描述
STUDY DESIGN:
Open, multicentre, phase II trial of atezolizumab with concurrent normofractionated radiotherapy in patients with histologically confirmed diagnosis of muscle-invasive urothelial carcinoma of the bladder.
The bladder preserving therapy include combined modality therapy with:
STUDY TREATMENTS:
Investigational product (atezolizumab/Tecentriq ®):
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Experimental arm
Atezolizumab 1200 mg intravenous infusion every 3 weeks for a total of 6 doses combined with External Beam Radiation Therapy (EBRT) (dosage: 60 Gy in 30 fractions overs 6 weeks at 2Gy/day)
干预措施: Atezolizumab Injection [Tecentriq] (Drug)
Experimental arm
Atezolizumab 1200 mg intravenous infusion every 3 weeks for a total of 6 doses combined with External Beam Radiation Therapy (EBRT) (dosage: 60 Gy in 30 fractions overs 6 weeks at 2Gy/day)
干预措施: External Beam Radiation Therapy (EBRT) (Radiation)
结局指标
主要结局
Pathological complete response
时间窗: After the end of the treatment (16 weeks)
Response of grade 5 according to Miller and Payne criteria
次要结局
- Disease specific survival(through study completion, up to 5 years)
- Muscle invasive and non-muscle invasive local failure(through study completion, up to 5 years)
- Overall survival(through study completion, up to 5 years)
- Disease free survival(through study completion, up to 5 years)
- Bladder-intact disease-free survival(through study completion, up to 5 years)
- Rate of patients with bladder preserved(through study completion, up to 5 years)
- Rate of distant metastases(through study completion, up to 5 years)
- Rate of immediate or late salvage cystectomy(through study completion, up to 5 years)
- The safety profile and tolerability of the combination of atezolizumab with concurrent radiotherapy(through study completion, up to 5 years)