NCT07090525招募中2 期
Bevacizumab Combined With Cisplatin Versus Cisplatin Monotherapy in Malignant Serous Effusions-A Prospective Randomized Controlled Study
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- overall response
研究概览
简要总结
The purpose of this study is to explore the efficacy and safety ofof bevacizumab plus cisplatin compare with cisplatin in the treatment of malignant serous effusion in patients with advanced adenocarcinoma
详细描述
This study is a prospective, three-center, randomized, phase II clinical study.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign informed consent;
- •Treatment naive serous effusion of patients with adenocarcinoma without activating gene mutation.
- •Eastern Cooperative Oncology Group (ECOG) score ≤ 2;
- •Survival is expected to exceed 3 months
排除标准
- •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
bevacizumab plus cisplatin arm
Experimental
干预措施: Intracavity injection of bevacizumab 7.5mg/kg plus cisplatin 40mg/m2 (Drug)
cisplatin arm
Active Comparator
cisplatin 40mg/m2 intracavity injection
干预措施: cisplatin 40mg/m2 intracavity injection (Drug)
结局指标
主要结局
overall response
时间窗: serous effusion ORR at 4 weeks
次要结局
未报告次要终点
研究者
Youxin Ji
director
Qingdao Central Hospital
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Bevacizumab, Cetuximab, and Cisplatin With IMRT (Intensity-Modulated Radiation Therapy) for Patients With Stage III/IV Head and Neck Squamous Cell CarcinomaHead and Neck CancerNCT00968435Memorial Sloan Kettering Cancer Center30
已完成
2 期
Bevacizumab Combined With Cisplatin Plus Pemetrexed as Front-line Chemotherapy for Asymptomatic Brain Metastases in Non-squamous Non-small Cell Lung Cancer.on-squamous Non-small Cell Lung CancerJPRN-UMIN000008811Hanshin Oncology Group35
已完成
2 期
Effect of Bevacizumab in Metastatic Triple Negative Breast CancerMetastatic Triple Negative Breast CancerSafety IssuesEfficacyNCT03577743Assiut University54
已完成
2 期
Carboplatin and Bevacizumab for Progressive Breast Cancer Brain MetastasesProgressive Breast CancerBreast CancerMetastatic Breast CancerNCT01004172Dana-Farber Cancer Institute38
已完成
2 期
Bevacizumab and Carboplatin/Paclitaxel and Radiation in Non-Small Cell Lung CancerNon-Small Cell Lung CancerNCT00578149Dana-Farber Cancer Institute45