Actively Recruiting
Bevacizumab Combined With Cisplatin Versus Cisplatin Monotherapy in Malignant Serous Effusions
Led by Qingdao Central Hospital · Updated on 2025-07-29
60
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Bevacizumab Combined With Cisplatin Versus Cisplatin Monotherapy in Malignant Serous Effusions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign informed consent
- Treatment-naive serous effusion in patients with adenocarcinoma without activating gene mutation
- Eastern Cooperative Oncology Group (ECOG) score of 2 or less
- Expected survival longer than 3 months
You will not qualify if you...
- Use of anti-vascular endothelial growth factor (VEGF) small molecule tyrosine kinase inhibitors or monoclonal antibodies in the past 4 weeks
- Participation in any clinical trial in the past 4 weeks
- Previous bevacizumab pleural perfusion therapy
- White blood cell count less than 3 x 10^9/L, neutrophil count less than 1.5 x 10^9/L, platelet count less than 75 x 10^9/L, or hemoglobin less than 8 g/dL
- Coagulation abnormalities with increased bleeding tendency or use of thrombolytic or anticoagulant treatment
- Serum total bilirubin greater than or equal to 1.5 times upper limit of normal (ULN)
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than or equal to 2.5 ULN without liver metastases, or greater than or equal to 5 ULN with liver metastases
- Serum albumin less than 30 g/L
- Serum creatinine greater than or equal to 1.5 ULN or creatinine clearance less than 40 ml/min
- Urine protein 2+ or more, or 24-hour urine protein greater than or equal to 1.0 g
- Uncontrolled hypertension
- Significant symptomatic heart disease such as congestive heart failure, symptomatic coronary heart disease, uncontrolled arrhythmia, recent myocardial infarction, or heart failure
- Imaging showing tumor lesions near large vessels or invasive central vasculature, significant lung tumor cavitation or necrosis, pneumothorax, or large/encapsulated bilateral pleural effusions
- Significant hemoptysis in past 6 months or daily hemoptysis of 2.5 ml or more
- Significant bleeding or bleeding tendency within 12 months before randomization
- Recent thrombosis or cancer thrombosis within 12 months
- Gastrointestinal diseases causing bleeding or perforation
- Severe respiratory diseases requiring long-term oxygen or corticosteroids
- Toxicity from previous cancer therapies not recovered to below grade 2
- Uncontrolled central nervous system metastasis
- Serious uncontrolled systemic diseases
- Active infections with HIV, hepatitis B, or hepatitis C
- Recent surgery within 28 days or unhealed wounds
- Known allergy to bevacizumab or components
- Pregnant or lactating females or reproductive-age patients unwilling to use contraception
- Serious psychological or mental abnormalities or lack of compliance
- Investigator judgment of other circumstances affecting study conduct
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Qingdao Central Hospital
Qingdao, Shandong, China, 266042
Actively Recruiting
Research Team
Y
youxin ji director of oncology, md, phD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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