Intrapleural Bevacizumab Injection for Malignant Effusion in Lung Cancer

Study Overview
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Brief Summary
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Malignant pleural or pericardial effusion is common in lung cancer, and intrapleural drugs injection is important in the treatment. Non- cytotoxic drugs include those with a sclerosing effect that produces pleurodesis, which is easy to cause severe chest pain despite of no influence on the following chemotherapy. Tumor angiogenesis is important in producing MPE. Bevacizumab has been administrated locally in treating optic nerve sickness successfully by anti-VEGF mechanism. So we hypothesize that intrapleural bevacizumab is also effective in treating MPE.

Detailed Description
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Inclusion Criteria: Histological or cytological diagnosis of non-small cell lung cancer. Cytological diagnosis of malignant pleural or pericardial effusion (MPE) Symptomatic MPE evaluated by researchers Unsuitable for or reject systemic therapy of tumor Continuous TKI treatment after TKI-resistance Estimated survival of more than 3 months. 7.18 years or older Exclusion Criteria: Current or recent (within 10 days prior to treatment) use the full amount of inhibition of platelet function, anticoagulants or thrombolytic therapy, which allows prophylactic anticoagulants Be allergic to bevacizumab Pregnant or lactating woman Pleural or pericardial infection

Official Title
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Intrapleural Bevacizumab Injection for Treating Malignant Pleural or Pericardial Effusion in Non-small Cell Lung Cancer

Conditions
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Non-small Cell Lung Cancer, Malignant Pleural Effusion

Intervention / Treatment
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* Drug: Bevacizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological or cytological diagnosis of non-small cell lung cancer. Cytological diagnosis of malignant pleural or pericardial effusion (MPE) Symptomatic MPE evaluated by researchers Unsuitable for or reject systemic therapy of tumor Estimated survival of more than 3 months. 6.18 years or older Exclusion Criteria: Current or recent (within 10 days prior to treatment) use the full amount of inhibition of platelet function, anticoagulants or thrombolytic therapy, which allows prophylactic anticoagulants Be allergic to bevacizumab Pregnant or lactating woman Pleural or pericardial infection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bevacizumab<br>Bevacizumab 100 mg, intrapleural injection treating maliganant pleural or percardial effusion | Drug: Bevacizumab<br>* Bevacizumab 100 mg, intrapleural injection treating MPE after the drainage of MPE<br>* Other names: Avastin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung cancer symptom |  | Evaluated by lung cancer symptom scale 21-30 days after the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate |  | Evaluate response rate 21-30 days after the treatment | 
| Time to progression |  | 1 year after the treatment of MPE. | 
| Overall survival |  | 1 year after the treatment of MPE | 
| Number of Participants with Adverse Events |  | one months after the treatment of MPE | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-small cell lung cancer, malignant pleural effusion, bevacizumab, intrapleural injection, pericardial effusion