A Single-arm Phase II Study of Endostar Combined With Corticosteroid for Treatment of Radiation-induced Brain Necrosis in Nasopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
To evaluate the effectiveness and safety of Endostar combined with corticosteroids on Radiation-induced Brain Necrosis in Nasopharyngeal Carcinoma patients.
detailed description:
详细描述
This was a single-arm, open-label study. We aimed to evaluate the effectiveness and safety of Endostar combined with corticosteroids on Radiation-induced Brain Necrosis in Nasopharyngeal Carcinoma patients. Magnetic resonance imaging (MRI) was performed pre- and post-treatment to define the radiographic response.The primary outcome was a 2-month response rate as determined by MRI and clinical symptoms. All of the patients were followed up with for 6 months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cytologically or histologically proven Nasopharyngeal Carcinoma(WHO 2003 I-III) .
- •Presence of at least one measurable target lesion (RECIST rules) in a non irradiated region;
- •age ≥18 years;
- •radiation therapy history for histologically confirmed NPC administered≥6 months prior to study entry;
- •radiographic evidence to support the diagnosis of RN with out tumor recurrence or metastases;
- •patients had never received Antiangiogenic agents for RN treatment prior to the screening;
- •patients had never received corticosteroids for RN treatment prior to the screening;
- •no evidence of very high intracranial pressure suggestive of a brain hernia requiring surgery routine laboratory studies including urinalysis, complete blood count, liver function, renal function, and coagulation test within a normal range;
- •to understand and be willing to sign a written informed consent.
排除标准
- •Other types of Nasopharyngeal Carcinoma;
- •Recurrent nasopharyngeal carcinoma, resection of encephalopathy, metastasis, hepatitis, other malignant tumors, neurovascular diseases, or other diseases of the nervous system;
- •Inadequately controlled diabetes (FBG > 10mmol/L) and hypertension(systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg);
- •Other severe concurrent disorders that occurred before enrollment (severe or unstable angor, NYHA class 3 or 4 congestive heart failure, Myocardial infarction occurred within 6 months before enrollment；Aortic dissection aortic aneurysm.) active central nervous system hemorrhage;
- •pregnant or lactating women, women who have not undergone a pregnancy test (within 14 days prior to initial administration), and pregnant women;
- •Patients with a history of severe mental illness or communication disorders.
研究组 & 干预措施
Endostar combined with Methylprednisolone
Endostar combined with Methylprednisolone lasts for 10 weeks
干预措施: Endostar (Drug)
结局指标
主要结局
ORR
时间窗: All of the patients were followed up with for 6 months.
2-month response rate as determined by MRI and clinical symptoms
次要结局
未报告次要终点