JPRN-UMIN000029144招募中2 期
Phase II clinical trial on clinical efficacy and safety of combination therapy of boron neutron capture therapy and bevacizumab for recurrent glioma with poor prognosis - Ava-boron for poor prognosis MG
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 15years-old 至 85years-old(—)
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Patients suspected of cerebral radiation necrosis at enrollment 2. Patients with infections requiring intravenous administration such as antibiotics, antivirals, antifungal drugs 3. Patients with fever (over 38C) 4. Patients with serious complications / previous medical history - Unstable angina pectoris, myocardial infarction complications, past within 6 months - Digestive ulcer with poor control - Poor control hypertension, diabetes - Advanced wounds that are not approved for healing, traumatic fractures - Digestive tract perforation, fistula, abdominal abscess complications, past within 6 months - Complication of CTCAE Grade 2 or higher pulmonary hemorrhage (hemoptysis [excretion of occult blood over 2.5 ml]), past history - Complication of vascular disorders (venous / arterial thrombus, embolism, aortic aneurysm) requiring treatment, past within 6 months - Complication of congestive heart failure of II degree or more in NYHA - Pulmonary fibrosis / interstitial pneumonia requiring treatment (CTCAE Grade 2 or higher) - Patients scheduled for surgery during the study or patients under 4 weeks from surgical therapy 5. Patients with phenylketonuria 6. Current bleeding (intracranial hemorrhage, gastrointestinal bleeding, urinary tract hemorrhage, retroperitoneal hemorrhage, hemoptysis, etc.) 7. Under anticoagulant medication, control is unstable or PT-INR is more than 2.5 8. Severe hypersensitivity to components of BPA and BV 9. Pregnant woman or lactating woman 10. Patients who do not agree to contraception participating in this study 11. Patients who participated in other clinical trials within one month prior to acquiring consent 12. Patients who are judged to be inappropriate for participation in this study by an investigator or a test sharing physician for other reasons
研究者
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