Bevacizumab plus cisplatin versus cisplatin for malignant serous effusions

Bevacizumab Combined With Cisplatin Versus Cisplatin Monotherapy in Malignant Serous Effusions-A Prospective Randomized Controlled Study

This study tests whether adding bevacizumab to intracavity cisplatin helps people with malignant serous effusions from advanced adenocarcinoma.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sex: All
• Sponsor: Qingdao Central Hospital (Academic / other)
• Drugs / interventions: bevacizumab
• Locations: 1 site (Qingdao, Shandong)
• Trial ID: NCT07090525 on ClinicalTrials.gov

What this trial studies

This is a prospective, randomized phase II study comparing intracavity bevacizumab (7.5 mg/kg) plus cisplatin (40 mg/m2) versus cisplatin (40 mg/m2) alone for control of malignant serous effusions. Patients are allocated to one of the two arms and receive intrapleural or intraperitoneal injections as appropriate, with response measured by overall response rate and safety monitoring. Key eligibility includes treatment‑naive malignant serous effusion from adenocarcinoma without activating gene mutations, ECOG ≤2, and expected survival >3 months. The protocol excludes recent anti‑VEGF therapy, prior intracavitary bevacizumab, significant coagulopathy, active anticoagulation, or inadequate blood counts.

Who should consider this trial

Good fit: Ideal candidates are patients with treatment‑naive malignant serous effusions from advanced adenocarcinoma without activating mutations, ECOG performance status 0–2, adequate blood counts and organ function, and no recent anti‑VEGF therapy.

Not a fit: Patients with active bleeding risk, recent anti‑VEGF therapy, prior intracavitary bevacizumab, severe coagulopathy, very low blood counts, or non‑adenocarcinoma causes of effusion are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, adding bevacizumab could improve fluid control and response rates, reducing the need for repeated drainage and easing symptoms.

How similar studies have performed: Small case series and early-phase studies of intracavitary bevacizumab have reported promising effusion control and symptom relief, but large randomized evidence is limited.

Eligibility criteria

Inclusion Criteria:

1. Voluntarily sign informed consent;
2. Treatment naive serous effusion of patients with adenocarcinoma without activating gene mutation.
3. Eastern Cooperative Oncology Group (ECOG) score ≤ 2;
4. Survival is expected to exceed 3 months

Exclusion Criteria:

* 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.

Where this trial is running

Qingdao, Shandong

• Qingdao Central Hospital — Qingdao, Shandong, China (Recruiting)

Study contacts

• Study coordinator: youxin ji director of oncology, md, phD

Conditions Overall Response Rate; Bevacizumab; malignant serous effusions; Randomized study