NCT03390062Unknown2 期
An One Arm, Open and Prospective Studyof Apatinib for the Treatment of Recurrent or Recurrent High-grade Glioma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 主要终点
- Progress-free Survival(PFS)
研究概览
简要总结
The purpose of this study is to determine the effectiveness and safety of Apatinib for patients with Recurrent or Recurrent High-grade Glioma.
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
- •Age ≥ 18 years old, male or female;
- •The histologically confirmed first-line after the surgical resection of the WHOIII / IV glioma or previous surgery and / or radiotherapy and chemotherapy after the recurrence of WHOIII / IV glioma;
- •ECOG score: 0-2 points;
- •The main organs function properly, that is, meet the following criteria:(1) blood test:a. HGB≥90 g / L;b. ANC ≧ 1.5 × 109 / L;c. PLT ≥80 × 109 / L;(2) biochemical examination:a. ALB≥30g / L;b. ALT and AST <2*ULN;c. TBIL≤1.5*ULN; d. Plasma Cr≤1.5 *ULN;
- •No history of mental illness in patients;
- •Thyroid function is normal;
- •Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up.
排除标准
- •Pregnant or lactating women;
- •Hypertensive patients who are not well controlled by antihypertensive medication (systolic blood pressure> 150 mmHg and diastolic blood pressure> 100 mmHg); those with grade I or greater myocardial ischemia or myocardial infarction, arrhythmia (including QT Period ≥ 440 ms) and grade I cardiac insufficiency, grading reference NCI-CTC AE 3.0;
- •Unable to swallow, chronic diarrhea and intestinal obstruction, significantly affect the medication and absorption;
- •Have a clear gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood ++ above), within 6 months history of gastrointestinal bleeding;
- •Have mental illness, or history of substance abuse;
- •Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogues; allowing the use of small doses of prophylaxis for prophylaxis, provided that the prothrombin time has an International Normalized Ratio (INR) ≤1.5 Farin (1 mg orally, once daily), low dose heparin (6,000 to 12,000 U daily for adults), or low dose aspirin (80 to 100 mg daily);
- •Researchers think it is not suitable for inclusion. All patients underwent CT or MRI of the head one week prior to the start of the protocol, with intracranial hemorrhage.
研究组 & 干预措施
apatinib
Experimental
apatinib 500 mg orally daily until the untolerabale toxicities、desease progress or death
干预措施: Apatinib (Drug)
结局指标
主要结局
Progress-free Survival(PFS)
时间窗: 24month
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
Overall Survival(OS)
时间窗: 24 month
The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.
次要结局
- EORTC QLQ-C30(24month)
- Objective Response Rate(ORR)(6month)
研究者
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