NCT02942043Unknown2 期
A Prospective, Multicenter, Randomized Controlled Clinical Trial of Bevacizumab in the Treatment of Malignant Pleural Effusions of Non-squamous Non-small Cell Lung Cancer
Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2016年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Pleural effusion ORR
研究概览
简要总结
The purpose of this study is to explore the efficacy and safety of different doses of bevacizumab injection in the treatment of malignant pleural effusion in patients with advanced non-squamous non-small cell lung cancer.
详细描述
This study is a prospective, multicenter, randomized, phase II clinical study. 87 patients will be recruited.
Group A (low dose group)
Intrapleural injection of bevacizumab 2.5mg/kg/times, d1, d8; 21 days for a course of treatment. Subjects will received two courses of treatment if there is no termination of treatment listed in the standard.
Group B (medium dose group)
Intrapleural injection of bevacizumab 5mg/kg/times, d1, d8; 21 days for a course of treatment. Subjects will received two courses of treatment if there is no termination of treatment listed in the standard.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Voluntarily sign informed consent;
- •Non-squamous non-small cell lung cancer, newly diagnosed or previously treated with systemic chemotherapy and / or epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors treatment;
- •B ultrasound, chest X-ray or CT examination to a large number of pleural effusion, with a cytology confirm of malignant pleural effusion;
- •Aged 18-75 years;
- •Eastern Cooperative Oncology Group (ECOG) score ≤ 2;
- •Survival is expected to exceed 8 weeks
排除标准
- •If any of the following criteria is met, the subject shall be excluded:
- •Squamous cell carcinoma (including adenosquamous carcinoma) and small cell lung cancer (including small cell carcinoma and non-small cell mixed lung cancer);
- •In the past 2 weeks, there have been systematic anti-tumor treatment including chemotherapy (including thoracic chemotherapy), radiotherapy (excluding radiotherapy of metastatic lesions outside the thoracic radiation field), targeted therapy, immunotherapy and biotherapy;
- •The subject had received anti-vascular endothelial growth factor (VEGF) small molecule tyrosine kinase inhibitors or monoclonal antibodies in the past 4 weeks;
- •The subject had participated any clinical trials in the past 4 weeks;
- •The subject had previously received bevacizumab of pleural perfusion therapy;
- •Laboratory results:
- •White blood cell count <3 × 109 / L, neutrophil count <1.5 × 109 / L, platelet <75 × 109 / L, or hemoglobin <8g / dL;
- •Coagulation abnormalities (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or activated partial thromboplastin time (APTT) > 1.5 ULN), with bleeding tendency or being treated with thrombolysis or anticoagulation;
- •Serum total bilirubin ≥1.5 ULN; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 ULN in the absence of liver metastases; ALT or AST ≥5 ULN in liver metastases;
- •Serum albumin <30g / L;
- •Serum creatinine ≥ 1.5 ULN or creatinine clearance <40ml / min;
- •Urine routine urinary protein ≥ ++, or 24 hours urine protein ≥ 1.0 g;
- •Hypertension cannot be controlled by drugs;
- •Heart disease with significant clinical symptoms, such as: congestive heart failure, coronary heart disease with symptom, arrhythmia hardly be controlled by drugs, myocardial infarction in 6 months, or heart failure;
- •Imaging (CT or MRI) showed a tumor lesion 5 mm away from the large vessels, or the presence of invasive central vasculature of the central tumor; imaging (CT or MRI) showed significant cavitation or necrosis of the lung tumor; Other diseases that may cause haemoptysis;
- •Imaging (CT or chest radiograph) showed significant pneumothorax, fluid pneumothorax;
- •Bilateral pleural cavity to a large number of effusion or encapsulated pleural effusion;
- •Obvious cough blood in 6 months, or daily hemoptysis amounted to half a teaspoon (2.5ml) or more;
- •Significant bleeding symptoms or with definite bleeding tendency within 12 months before randomization, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, occult blood ++ and above, intracerebral hemorrhage, vasculitis, or with congenital or acquired coagulopathy disorders;
- •Thrombosis, cancer thrombosis (including arteriovenous thrombosis, tumor thrombus, pulmonary embolism, transient ischemic attack, etc.) occurred within 12 months;
- •There are gastrointestinal obstruction, peptic ulcer, Crohn's disease, ulcerative colitis and other gastrointestinal diseases or other diseases may cause gastrointestinal bleeding or perforation;
- •Severe respiratory diseases, or need long-term oxygen, corticosteroid treatment of diseases such as chronic obstructive pulmonary disease, interstitial lung disease and respiratory failure;
- •The toxicity of previous antineoplastic therapies has not yet recovered to below grade 2 or has not fully recovered;
- •Patients with uncontrolled central nervous system metastasis;
- •There are serious uncontrolled systemic diseases, such as nephrotic syndrome, infection, poorly controlled diabetes;
- •Patients with active HIV（human immunodeficiency virus）, HBV（hepatitis B virus）, or HCV（hepatitis C virus） infection;
- •Patients had undergone surgery (<28 days) or did not heal completely, or had other unhealed wounds before the study;
- •Patients known to be allergic to bevacizumab or any of the components of the drug;
- •Pregnant or lactating female patients, or unwilling to take contraceptive measures of reproductive age patients (including men);
- •There is a serious psychological or mental abnormality, or lack of compliance;
- •The investigator determines other circumstances that may affect the conduct of clinical studies and the determination of findings.
研究组 & 干预措施
Group A (low dose group)
Experimental
Intrapleural injection of bevacizumab 2.5mg/kg/times, d1, d8; 21 days for a course of treatment. Subjects will received two courses of treatment if there is no termination of treatment listed in the standard.
干预措施: Bevacizumab (Drug)
Group B (medium dose group)
Experimental
Intrapleural injection of bevacizumab 5mg/kg/times, d1, d8; 21 days for a course of treatment. Subjects will received two courses of treatment if there is no termination of treatment listed in the standard.
干预措施: Bevacizumab (Drug)
Group C (high dose group)
Experimental
Intrapleural injection of bevacizumab 7.5mg/kg/times, d1, d8; 21 days for a course of treatment. Subjects will received two courses of treatment if there is no termination of treatment listed in the standard.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Pleural effusion ORR
时间窗: 1 year
次要结局
- ORR(1 year)
- Pleural fluid TTP(1 year)
- OS(1 year)
- QOL scores(2 month)
- Safety (NCI CTCAE V4.03)(2 month)
研究者
Jian Fang
Director, Head of thoracic oncology
Peking University Cancer Hospital & Institute
研究点 (1)
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