NCT05201326招募中1 期
An Open and Single-arm Prospective Clinical Study of the Safety and Efficacy of Irinotecan and Bevacizumab Combined With Re-radiotherapy in the Treatment of Recurrent Glioblastoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- serious adverse events (SAE)
研究概览
简要总结
This is a phase I study to observe the safety and efficacy of irinotecan and bevacizumab combined with re-radiotherapy in the treatment of recurrent glioblastoma. The study will provide a higher level of clinical evidence-based evidence for the clinical treatment of recurrent GBM, and fill the guidelines for the treatment of recurrent GBM.
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
- •The initial diagnosis confirmed by histopathology is World Health Organization WHO grade 4 glioma;
- •Surgery, radiotherapy, chemotherapy, and adjuvant chemotherapy (Stupp plan) are performed after the initial diagnosis, and recurrence according to the evaluation of neurotumor response (RANO) criteria and/or confirmed by histopathology;
- •The expected survival period is ≥3 months;
- •Age between 18 and 70 years old;
- •KPS score (KPS) ≥ 70, able to take care of most of life, but occasionally need help from others;
- •There are measurable lesions on the T1 enhancement sequence of the head MRI;
- •Hematopoietic function: hemoglobin ≥90g/L, platelets ≥90×109/L, white blood cells ≥4×109/L (previous chronic anemia 80-90 g/L or previous low white blood cell level 3-4×109/L Or thrombocytopenia 80-90×109/L, but KPS 70-100 can be considered for admission) (The range of normal values can be fine-tuned due to the different standards of tertiary first-class hospitals);
- •Liver function: ALT and AST<1.5 times of high normal (ULN), bilirubin<1.5×ULN;
- •Sign the informed consent form;
- •Agree to participate in follow-up actions.
排除标准
- •Other invasive malignant tumors;
- •Re-irradiation after receiving recurrence in the past;
- •Recurrence more than 3 times or evidence that there is a subdural recurrence disease or a tumor with a maximum diameter of more than 6 cm;
- •Treat with vascular endothelial growth factor (VEGF) or VEGFR inhibitor or irinotecan in advance;
- •Pregnant or nursing mothers;
- •Participate in other tests after diagnosis of recurrence;
- •According to CTCAE5.0 standard classification of patients with bleeding above grade 3;
- •Symptomatic peripheral vascular disease;
- •Known allergy to bevacizumab or irinotecan;
- •Patients who are treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogs; under the premise that the prothrombin time international normalized ratio (INR) is ≤1.5, the use of small doses of Huafa for preventive purposes is allowed Farin (1 mg orally, once a day) or low-dose aspirin (do not exceed 100 mg per day);
- •Abnormal blood coagulation function, bleeding tendency (such as active peptic ulcer) or receiving thrombolysis or anticoagulation therapy;
- •Arterial/venous thrombotic events that occurred within 6 months before the first medication, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism;
- •Urine routine test showed urine protein ≥++ and confirmed 24-hour urine protein quantification>1.0 g;
- •Long-term unhealed wounds or fractures;
- •Suffering from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poor arrhythmia control (including men with QTc interval ≥450 ms, women ≥470 ms); according to NYHA standards, III to Grade IV insufficiency or color Doppler ultrasonography of the heart shows that the left ventricular ejection fraction (LVEF) is less than 50%;
- •Patients with hypertension who cannot be well controlled by a single antihypertensive drug treatment (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg), suffering from myocardial ischemia or myocardial infarction, arrhythmia (including QT room Period ≥440 ms) and degree I cardiac insufficiency;
- •History of organ transplantation;
- •According to the judgment of the researcher, a serious disease that endangers the safety of the patient or affects the completion of the study.
- •Poor overall health, even KPS<60;
- •Unable to understand the purpose of treatment or unwilling to sign the treatment consent form;
- •No capacity for civil conduct or limited capacity for civil conduct.
研究组 & 干预措施
Treatment arm
Experimental
irinotecan + bevacizumab + Re-radiotherapy
干预措施: Bevacizumab，Irinotecan and Re-radiotherapy (Drug)
结局指标
主要结局
serious adverse events (SAE)
时间窗: From baseline to 28 days after the end of treatment
Clinical safety
次要结局
- overall survival(From the beginning of treatment to death or the last follow-up, approximately 24 months)
- progression free survival(From the start of treatment to the date of disease progression or death, up to approximately 24 months)
研究者
JIAYI CHEN
Chief of Department of Radiation Oncology
Ruijin Hospital
研究点 (1)
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