Safety and Efficacy of LITT Combined With Early Use of Temozolomide for Recurrent Glioblastomas
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
This study aims to investigate the safety and efficacy of Laser Interstitial Thermal Therapy (LITT) combined with postoperative early use of temozolomide in treating recurrent glioblastomas.
详细描述
This is an open-label, non-randomized Phase II study, planning to recruit about ten patients.
The primary objective of this study is to investigate the safety of MRI-guided LITT in combination with the early application of temozolomide.
The secondary outcome is to explore the efficacy of MRI-guided LITT combined with the early use of temozolomide in treating recurrent glioblastomas.
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
- •Imaging (PET-MRI) indicates tumor progression or recurrence
- •Patient ≥18 years old
- •The tumor was the first-time recurrence
- •The pathology of the tumor is glioblastoma (IDH wild-type, WHO grade 4)
- •MRI indicated a single tumor or multiple tumors with visual enhancement =<3cm
- •Maximum tumor diameter: single tumor =<3cm; Multiple tumors, targeted lesion =<3cm
- •Single tumor or one of the multiple tumor lesions involved deep functional areas such as the insula lobe or thalamus
- •KPS score >=60 within 30 days before treatment
- •No serious liver or kidney dysfunction
- •Patients must be able to understand how to sign the informed consent document
排除标准
- •The tumor crossed the midline or involved bilateral cerebral hemispheres
- •Inability to perform MRI examination or intolerance to MRI contrast agent
- •There is an active infection of the patient
- •The patient had abnormal coagulation function
- •Imaging before treatment indicated signs of cerebral hernia or midline displacement > 1.0cm
- •The patient received radiotherapy, chemotherapy (including immunotherapy), or other therapeutic measures after tumor recurrence
- •Patients who have participated in clinical trials of any other drug or medical device within three months of the screening.
- •KPS score =<50 points
研究组 & 干预措施
LITT with Early Application of Temozolomide
Patients will receive the early use of temozolomide sooner after Laser interstitial thermal therapy (LITT).
干预措施: Laser interstitial thermal therapy (Procedure)
LITT with Early Application of Temozolomide
Patients will receive the early use of temozolomide sooner after Laser interstitial thermal therapy (LITT).
干预措施: Temozolomide (Drug)
结局指标
主要结局
Adverse Events
时间窗: From Day 1 throughout the study until 3 months
To complete protocol treatment without undue treatment-related acute toxicity in recurrent glioblastoma patients undergoing LITT followed by early use of temozolomide.
次要结局
- Time to Progression (TTP)(12 months)
- Overall survival (OS)(18 months)
研究者
Dabiao Zhou, MD
Clinical Professor
Beijing Tiantan Hospital