A Multicenter, Prospective, Open and Single Arm Clinical Study of Nimotuzumab Combined With Concurrent Radiochemotherapy in the Treatment of Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) in Children
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 8
- 主要终点
- Objective response rate #ORR# assessed by the Independent Review Committee
研究概览
简要总结
This is a prospective, open-label, single arm, multicenter clinical study. The purpose of the study is to evaluate the clinical efficacy and safety of combination Nimotuzumab with concurrent radiochemotherapy in children with newly diagnosed diffuse intrinsic pontine glioma(DIPG).
详细描述
This clinical study is designed as a prospective, open-label, single arm, multicenter study to evaluate the clinical efficacy and safety of combination Nimotuzumab with concurrent radiochemotherapy in children with newly diagnosed diffuse intrinsic pontine glioma(DIPG). The main endpoint is objective response rate, 1-year overall survival rate is also observed.
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
- 3 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary and sign a consent form;
- •Age 3-15 years old, gender unlimited;
- •Histology or imaging diagnosed as diffuse intrinsic pontine glioma, patients haven't received any anti-tumor treatment;
- •According to the RANO criteria, at least one measurable lesion;
- •Before enrollment, the results of laboratory examination are in accordance with:
- •Blood routine test: platelet count ≥ 100 × 10^9/L; absolute neutrophil count ≥ 1.5 × 10^9/L or leukocyte count ≥ 3.0 × 10^9/L; hemoglobin ≥ 90g/L; Blood biochemistry: aspartate aminotransferase#AST# ≤ 3 ×Upper Limit Of Normal#ULN#; alanine aminotransferase#ALT# ≤ 3 × ULN; total bilirubin ≤ 1.5 × ULN; serum creatinine ≤ 1.5 × ULN;
- •Lansky score ≥ 60;
- •Expected survival time ≥ 3 months;
- •Fertile subjects are willing to take contraceptive measures during the study period.
排除标准
- •Recurrent DIPG;
- •Have received any other anti-tumor treatment for DIPG, including surgical treatment (except biopsy), chemotherapy, radiotherapy, targeted drugs, immunotherapy, etc;
- •Uncontrollable infection, epilepsy and / or hypertension and / or hyperglycemia;
- •Human immunodeficiency virus #HIV# infection or active hepatitis B infection or hepatitis C infection;
- •Active hemorrhage found by CT or MRI before inclusion and / or inability to carry out CT and MRI examination;
- •Major operation (except biopsy) were performed within four weeks before inclusion;
- •Decompensated heart failure (NYHA grades III and IV), unstable angina, acute myocardial infarction, persistent and clinically significant arrhythmia within three months of inclusion;
- •Have other malignant tumor history;
- •Known allergy to Nimotuzumab, temozolomide or its analogues or any component of the prescription;
- •Unable to tolerate radiotherapy;
- •Other reasons that are not suitable to participate in this study according to the researcher's judgment.
研究组 & 干预措施
Experimental
Nimotuzumab+CRT(concurrent IMRT and TMZ)
干预措施: Nimotuzumab+CRT(concurrent IMRT and TMZ) (Drug)
结局指标
主要结局
Objective response rate #ORR# assessed by the Independent Review Committee
时间窗: Up to 12 months
Proportion of patients with partial or complete response in tumor burden as defined by RECIST.
次要结局
- Progression-free survival#PFS#(Up to 12 months)
- 1-year overall survival(Up to 12 months)
- Incidence of adverse events(Up to 30 days after last administration of Nimotuzumab)