Actively Recruiting
Bevacizumab Combined With Cisplatin Versus Cisplatin Monotherapy in Malignant Serous Effusions A Prospective Randomized Controlled Study
Led by Qingdao Central Hospital · Updated on 2025-07-29
60
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining bevacizumab with cisplatin compared to cisplatin alone for treating malignant serous effusion in patients with advanced adenocarcinoma. This is a phase II, three-center, randomized clinical study sponsored by Qingdao Central Hospital. The study focuses on overall response rates at 4 weeks to understand how well the treatments control serous effusion in this patient group. Participants will be randomly assigned to one of two treatment groups. One group receives an intracavity injection of bevacizumab at 7.5 mg/kg combined with cisplatin at 40 mg/m2, with a repeat dose on the 21st day if the serous effusion is not controlled. The other group receives cisplatin alone at 40 mg/m2 via intracavity injection. Both treatments are administered directly into the cavity where the effusion is present. During the study, participants will be monitored for treatment response at 4 weeks to assess the overall response rate of the serous effusion. Safety and efficacy are carefully observed throughout the treatment period. Patients must meet specific health and laboratory criteria to participate, and their progress will be tracked to ensure their well-being and to gather important data on the treatments' effects. The study is expected to run until May 2027.
CONDITIONS
Brief 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 of patients with adenocarcinoma without activating gene mutation
- Eastern Cooperative Oncology Group (ECOG) score ≤ 2
- Survival is expected to exceed 3 months
You will not qualify if you...
- Received anti-VEGF small molecule tyrosine kinase inhibitors or monoclonal antibodies in past 4 weeks
- Participated in any clinical trials in past 4 weeks
- Previously received bevacizumab pleural perfusion therapy
- White blood cell count <3 × 10⁹ / L, neutrophil count <1.5 × 10⁹ / L, platelet <75 × 10⁹ / L, or hemoglobin <8 g / dL
- Coagulation abnormalities or bleeding tendency
- Serum total bilirubin ≥1.5 ULN
- ALT or AST elevated ≥2.5 ULN without liver metastases or ≥5 ULN with liver metastases
- Serum albumin <30 g / L
- Serum creatinine ≥1.5 ULN or creatinine clearance <40 ml / min
- Urine protein ≥++ or 24-hour urine protein ≥1.0 g
- Uncontrolled hypertension
- Significant heart disease or recent myocardial infarction
- Tumor lesion near large vessels or invasive central tumor vasculature on imaging
- Significant lung tumor cavitation or necrosis on imaging
- Diseases causing hemoptysis
- Significant pneumothorax or fluid pneumothorax on imaging
- Large or encapsulated bilateral pleural effusion
- Recent or significant hemoptysis
- Significant bleeding symptoms or bleeding tendency within 12 months
- Recent thrombosis or cancer thrombosis within 12 months
- Gastrointestinal diseases causing bleeding or perforation
- Severe respiratory diseases requiring long-term oxygen or steroid treatment
- Toxicity from previous therapies not recovered below grade 2
- Uncontrolled central nervous system metastasis
- Serious uncontrolled systemic diseases
- Active HIV, hepatitis B, or hepatitis C infection
- Recent surgery (<28 days) or unhealed wounds
- Allergy to bevacizumab or drug components
- Pregnant, lactating, or unwilling to use contraception if of reproductive age
- Serious psychological or mental abnormality
- Other conditions affecting study conduct as determined by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks
Participants receive intracavity injections of either bevacizumab combined with cisplatin or cisplatin alone. The treatment may be repeated on the 21st day if the serous effusion is not controlled.
1 to 2 visits depending on treatment response
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
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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