A Study to Evaluate the Safety and Efficiency of Using the Neoadjuvant Therapy With Carilizumab and Apatinib in Patients With Recurrent High-Grade Glioma ：A Prospective, Randomized Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
GBM is the most common intracranial tumor in adults, accounting for about 40% of all primary intracranial tumors.Although surgery, radiotherapy and chemotherapy have been used, the prognosis of glioma patients is still very poor. The study aim to Evaluate the Safety and efficiency of Using the neoadjuvant therapy with Carilizumab and Apatinib in patients with Recurrent High-Grade Glioma.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent.
- •Age 18-70 years old, both male and female.
- •After biopsy or surgery, the postoperative pathological diagnosis was WHO III-IV glioma.
- •Patients in whom surgery can be safely delayed for a minimum period of 2 weeks following the administration of the first dose of nivolumab, in the opinion of the investigator.
- •KPS score ≥60；
- •Life expectancy >12 weeks.
- •Adequate organ function defined by:
- •HGB≥110g/L；
- •WBC≥3.0×109/L；NEUT≥1.5×109/L；
- •PLT ≥75×109/L；
- •BIL≤1.5ULN；
- •ALT and AST≤2.0×ULN；
- •creatinine < 1.5 x ULN or estimated creatinine clearance≥50ml/min（using the Cockcroft-Gault formula）
排除标准
- •Presence of extracranial disease.
- •Previous treatment with a PD-1, PDL-1 or CTLA-4，VEGFR targeted therapy.
- •Pregnant or breastfeeding patients.
- •Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). Routine testing is not required.
- •Positive tests for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection.
- •History of allergy to study drug components or of severe hypersensitivity reactions to any monoclonal antibodies.
- •Known drug or alcohol abuse.
研究组 & 干预措施
Neoadjuvant group
Patients need to treat with PD-1 and apatinib before surgery. Sequential therapy with PD-1 and apatinib when patients accepted surgery.
干预措施: PD-1 (Biological)
Adjuvant group
Before surgery, patients no need to treat with PD-1 and apatinib. Sequential therapy with PD-1 and apatinib when patients accepted surgery.
干预措施: PD-1 (Biological)
结局指标
主要结局
Overall survival (OS)
时间窗: 3 years
Time from enrollment to the dates of death from any cause or last follow up reported between date of first patient enrollment
次要结局
- Progression-free survival(PFS)(18 months)
研究者
Zhongping Chen
Clinical Professor
Sun Yat-sen University