Efficacy and Safety of Nimotuzumab in Addition to Radiotherapy and Temozolomide for Cerebral Glioblastoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 5
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This study aimed to investigate the clinical benefit contribution and safety of nimotuzumab to the standard combined treatment for patients with newly diagnosed glioblastoma.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed, histologically proven single supratentorial GBM (WHO grade 4);
- •EGFR positive;
- •>50％ of the gross tumor volume removed by surgery；
- •Karnofsky performance score (KPS) ≥ 60;
- •Adequate renal function (creatinine ≤1.5×upper limit of normal [ULN] or creatinine clearance ≥ 60 mL/min), hepatic function (total bilirubin ≤1.5×ULN and serum transaminases ≤3×ULN), and hematologic function (white blood cell count ≥ 3,000/uL or absolute neutrophil count ≥ 1,500/uL, platelets ≥ 100,000/uL, and hemoglobin ≥ 10 g/dL).
- •Tumor tissue was required for central pathology review and re-checking EGFR and MGMT expression status;
- •An interval of 2 to 6 weeks between surgery and RT was required.
排除标准
- •Negative EGFR expression;
- •Prior chemotherapy, anti-EGFR therapy, RT, or a history of malignancy in the previous 5 years;
- •Patients with severe complications or active infection;
- •Continuous vomiting that could interfere with the oral administration of TMZ;
- •Pregnancy
研究组 & 干预措施
Nimotuzumab plus RT and temozolomide.
Nimotuzumab, administered once a week intravenously in addition to radiotherapy with concomitant and adjuvant temozolomide (TMZ) after surgery.
干预措施: Nimotuzumab (Biological)
Nimotuzumab plus RT and temozolomide.
Nimotuzumab, administered once a week intravenously in addition to radiotherapy with concomitant and adjuvant temozolomide (TMZ) after surgery.
干预措施: Temozolomide (Drug)
Nimotuzumab plus RT and temozolomide.
Nimotuzumab, administered once a week intravenously in addition to radiotherapy with concomitant and adjuvant temozolomide (TMZ) after surgery.
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: 2 years
PFS will be calculated as the time from surgery to the date of progression-free.
Overall survival (OS)
时间窗: 2 years
OS will be calculated as the time from surgery to the date of death.
次要结局
- Incidence of adverse events(6 months)
- Objective Response Rate (ORR)(6 months)
研究者
Shao Xiong Wu
Professor
Sun Yat-sen University