A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Trial to Evaluate Safety and Efficacy pf ASC40 Tablets Combined With Bevacizumab in Subjects With Recurrent Glioblastoma
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
This is a randomized, double-blind, controlled and multi-center Phase III clinical trial to evaluate the safety and efficacy of ASC40 tablets combined with bevacizumab in the treatment of adult patients with recurrent glioblastoma. After standard radiotherapy and chemotherapy (temozolomide), the subject first experienced clinical recurrence or progression.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age ≥18 years old, both male and female;
- •Histologically confirmed glioblastoma;
- •Patients with glioblastoma who have failed standard treatment (surgery, Stupp regimen), were diagnosed by MRI and evaluated by RANO standard to support the first recurrence. Stupp regimen needs to complete at least 6 medication cycles.
排除标准
- •Use low molecular weight heparin and warfarin within 35 days before randomization;
- •Arterial or venous thrombosis (such as cerebral infarction, myocardial infarction, venous thrombosis of lower limbs, arterial embolism of lower limbs, pulmonary embolism, etc.) occurred within 6 months before randomization
研究组 & 干预措施
ASC40
ASC40 tablets 100mg/m^2 and bevacizumab 10mg/kg.
干预措施: Bevacizumab (Drug)
ASC40
ASC40 tablets 100mg/m^2 and bevacizumab 10mg/kg.
干预措施: ASC40 tablets (Drug)
Placebo
Placebo and bevacizumab 10mg/kg.
干预措施: Placebo tablets (Drug)
Placebo
Placebo and bevacizumab 10mg/kg.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Progression-free survival
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
The time of progression or death from any cause in randomly grouped diseases (whichever comes first) was compared with the control group (evaluated by Independent Imaging Evaluation Committee \[IRC\])
Total survival
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months
the time from random grouping to death, compared with the control group.
次要结局
- Objective remission rate(Week 4 to Month 6 (every 8 weeks))