Efficacy and Safety of Bevacizumab Versus Pulvis Talci in Malignant Pleural Effusion

Study Overview
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Brief Summary
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Patients with Malignant pleural effusion can be diagnosis advanced cancer. Currently recognized as the most reliable method to control malignant pleural effusion is pleural fixed or thoracic catheter drainage. The most effective pleural fixed agent is pulvis talci, but there are about 30% relapse rate. Thoracic drainage can lead to some complications, such as chest infections, catheter migration and blockage etc. The investigators need a reliable methods to solve dyspnea and other symptoms caused by malignant pleural effusion, and improve quality of life. The purpose of this study was to determine the efficacy and Safety of intrapleural Bevacizumab versus pulvis talci as treatment for malignant pleural effusions (MPE) in patients.

Detailed Description
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Background： Patients with Malignant pleural effusion can be diagnosis advanced cancer. Currently recognized as the most reliable method to control malignant pleural effusion is pleural fixed or thoracic catheter drainage. The most effective pleural fixed agent is pulvis talci, but there are about 30% relapse rate. Thoracic drainage can lead to some complications, such as chest infections, catheter migration and blockage etc. The investigators need a reliable methods to solve dyspnea and other symptoms caused by malignant pleural effusion, and improve quality of life. The purpose of this study was to determine the efficacy and Safety of intrapleural Bevacizumab versus pulvis talci as treatment for malignant pleural effusions (MPE) in patients. Methods: A unblended, randomized study to compare the inhibition of two treatment methods in malignant pleural effusion. Consecutive 183 patients were randomly assigned to two groups, A group is Bevacizumab200mg by intrapleural administration; B group is injected pulvis talci with closed thoracic drainage.

Official Title
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Efficacy and Safety of Intrapleural Bevacizumab Versus Pulvis Talci in Malignant Pleural Effusion, A Randomized, Multicenter Study

Conditions
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Malignant Pleural Effusion

Intervention / Treatment
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* Drug: Bevacizumab
* Drug: Pulvis talci


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnose malignant pleural effusions by: Diagnose malignant pleural neoplasms by histopathology Recurrent pleural effusion, Histologically or cytologically confirmed diagnosis of cancer Written informed consent Exclusion Criteria: <18years of age Expected survival <3 months Chest infection, chylothorax, pleurodesis or ipsilateral lung surgery once Planned chemotherapy Pregnancy or breast-feeding (women of child-bearing potential) Not signed informed consent or non-compliance with treatment protocols

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bevacizumab<br>Bevacizumab200mg by intrapleural administration | Drug: Bevacizumab<br>* Bevacizumab200mg by intrapleural administration<br>* Other names: Avastin;|
| Active Comparator: Pulvis talci<br>Pulvis talci 4g by intrapleural administration | Drug: Pulvis talci<br>* Pulvis talci 4g by intrapleural administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in chest drainage | Observed chest drainage every day | up to 3months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the average daily VAS defining breathlessness | VAS: Visual Analogue Scale | up to 1 year | 
| Average daily thoracalgia assessed using VAS score | VAS: Visual Analogue Scale | up to 1 year | 
| percentage of adverse reactions |  | up to 1 year | 
| Length of Stay |  | up to 1 year |