A Single-arm, Phase II Study of Nimotuzumab Combined With the Stupp Regimen for Postoperative Residual Glioblastoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Progression-Free Survival
研究概览
简要总结
This is a prospective, single-arm study. The study population consists of adult patients with a confirmed diagnosis of EGFR-positive high-grade glioma who have radiographic residual tumor following surgical resection. Participants will receive nimotuzumab in combination with the standard Stupp regimen after glioma surgery.
详细描述
This is a prospective, single-arm study designed to enroll 50 adult patients with a confirmed diagnosis of EGFR-positive high-grade glioma and radiographic residual tumor following surgical resection (primary inclusion criteria). Patients are excluded if they are EGFR-negative; have previously received chemotherapy, anti-EGFR therapy, or radiotherapy; have a history of other malignancies within the past 5 years; present with severe comorbidities or active infections; or experience persistent vomiting that may interfere with the oral administration of temozolomide (TMZ). Following surgery, participants will receive nimotuzumab in combination with the standard Stupp regimen.
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
- •1）Aged 18 to 75 years.
- •2）Newly diagnosed glioblastoma consistent with the World Health Organization (WHO) Classification of Tumours of the Central Nervous System, 5th edition.
- •3）Epidermal growth factor receptor (EGFR)-positive status confirmed by immunohistochemistry (defined as brown-yellow staining in >10% of tumor cells).
- •4）Partial surgical resection with radiographically measurable residual tumor.
- •5）Karnofsky Performance Status (KPS) score ≥ 50% (with KPS decline attributable to the tumor).
- •6）Adequate renal function, defined as serum creatinine ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance > 60 mL/min.
- •7）Adequate hepatic function, defined as total bilirubin ≤ 1.5 times the ULN and serum transaminases ≤ 3 times the ULN.
- •8）Adequate hematologic function, defined as a white blood cell count ≥ 3,000/μL or an absolute neutrophil count (ANC) ≥ 1,500/μL, platelet count ≥ 100,000/μL, and hemoglobin ≥ 10 g/dL.
- •9）An interval of 2 to 6 weeks between surgical resection and the initiation of radiotherapy (RT).
排除标准
- •1）EGFR-negative status.
- •2）Prior treatment with chemotherapy, anti-EGFR therapy, or radiotherapy; or a history of other malignancies within the past 5 years.
- •3）Presence of severe comorbidities or active infections, or persistent vomiting that may interfere with the oral administration of temozolomide (TMZ).
结局指标
主要结局
Progression-Free Survival
时间窗: from the initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, up to 100 weeks
defined as the time from randomization (or the initiation of treatment) to the first documented tumor progression or death from any cause, whichever occurs first
次要结局
- Overall Survival(from the initiation of treatment，up to 100 weeks)
- Objective Response Rate(through study completion, an average of 1 year)
- Disease Control Rate(through study completion, an average of 1 year)
- Adverse Event(through study completion, an average of 1 year)
研究者
Wei Jiang
Professor
Tianjin First Central Hospital