NCT03389087Unknown2 期
Single Arm, Exploratory and Open Phase II Clinical Trial of Apatinib Plus Etoposide Capsule as the Therapy of Advanced Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
The purpose of this study is to confirm the safety and efficacy of Apatinib Plus Etoposide Capsule as the Therapy of Advanced Small Cell Lung Cancer.
详细描述
Small cell lung cancer is a very aggressive cancer, often accompanied by distant metastases, with a poor prognosis. 5-year survival rate of less than 5%, untreated patients with an average survival of only 2-4 months. The investigators consider to add apatinib,a tyrosine kinase inhibitor of VEGF,to the therapy of these patients. The investigators designed the study to explore the possibility of apatinib Plus Etoposide Capsule as the Therapy of Advanced Small Cell Lung Cancer.
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
- •Pathological diagnosis of small cell lung cancer.
- •≥ 18 and ≤ 75 years of age.
- •According to RESCIST1.1 standard, there are evaluable target lesions.
- •Has received second-line standard treatment of recurrent or metastatic extensive stage small cell lung cancer.
- •Life expectancy of more than 3 months.
- •Eastern Cooperative Oncology Group(ECOG) performance status 0 or
- •Adequate hepatic, renal, heart, and hematologic functions: ANC ≥ 1.5×109/L, PLT ≥ 100×109/L, HB ≥ 90 g/L, TBIL ≤ 1.5×ULN, ALT or AST ≤ 2.5×ULN (or ≤ 5×ULN in patients with liver metastases), Serum Cr ≤ 1.25×ULN, Cr clearance ≥ 45 mL/min.
- •Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of apatinib until 6 months after discontinuing study drug. Male subjects must agree to use contraceptive measures during the study and 6 months after last dose of study drug.
- •Signed the informed consent form prior to patient entry.
排除标准
- •Active brain metastases, meningococcal meningitis, patients with spinal cord compression, or imaging at CT or MRI examination revealed brain or pia mater disease（Patients who have completed treatment and whose symptoms are stable in the first 21 days of randomization may be enrolled in the study but may be diagnosed as having no intracerebral hemorrhage by MRI, CT or venography）；
- •Imaging (CT or MRI) showed that the tumor lesions were ≤ 5 mm from the major vessels or there was a central tumor invading local macrovascular；
- •Imaging (CT or MRI) showed significant cavitary or necrotic lung tumors, uncontrollable hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg, despite optimal medical therapy), grade II The above myocardial ischemia or myocardial infarction, poor control of arrhythmia (including QTc interval male ≥ 450 ms, female ≥ 470 ms); NYHA standards, Ⅲ ~ Ⅳ grade cardiac insufficiency, or cardiac ultrasound examination prompted left ventricular ejection Score (LVEF) <50%；
- •Coagulation dysfunction (INR> 1.5, PT> ULN +4s or APTT> 1.5 ULN), with bleeding tendency or ongoing thrombolysis or anti-blood coagulation treatment；Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or the like；
- •Patients who had obvious hemoptysis within 2 months before screening, or experienced daily hemoptysis with a volume more than half a tea spoon (2.5ml) or above；
- •Patients who experienced bleeding symptoms of clinical significance within 3 months before screening, or with confirmed bleeding tendency such as hemorrhage of digestive tract, hemorrhagic gastric ulcer, baseline occult blood in stool ++ and above, or vasculitis, etc.
- •Patients who manifested arterial/venous thrombus events, e.g. cerebrovascular accident (Including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism, etc., within 12 months before screening（Such as hemophilia, coagulation disorders, thrombocytopenia, hypersplenism and so on）；
- •Patients whose routine urine tests indicate that urine protein ≥ ++ or verifies that the 24-h urine protein quantitation ≥ 1.0 g；
- •Previously used anti-angiogenic drugs.
研究组 & 干预措施
Apatinib and Etoposide Capsule
Experimental
Apatinib and Etoposide Capsule
干预措施: Apatinib and Etoposide Capsule (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: up to 2 year
From date of randomization until the date of first documented progression or date of death from any cause
次要结局
- Overall survival(OS)(up to 2 year)
- Objective Response Rate (ORR)(up to 1 year)
研究者
研究点 (1)
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