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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

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.

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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.

Conditions

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Malignant Pleural Effusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bevacizumab

Bevacizumab200mg by intrapleural administration

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type DRUG

Bevacizumab200mg by intrapleural administration

Pulvis talci

Pulvis talci 4g by intrapleural administration

Group Type ACTIVE_COMPARATOR

Pulvis talci

Intervention Type DRUG

Pulvis talci 4g by intrapleural administration

Interventions

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Bevacizumab

Bevacizumab200mg by intrapleural administration

Intervention Type DRUG

Pulvis talci

Pulvis talci 4g by intrapleural administration

Intervention Type DRUG

Other Intervention Names

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Avastin

Eligibility Criteria

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Inclusion Criteria

1. Diagnose malignant pleural effusions by:

* Diagnose malignant pleural neoplasms by histopathology
* Recurrent pleural effusion, Histologically or cytologically confirmed diagnosis of cancer
2. Written informed consent

Exclusion Criteria

1. \<18years of age
2. Expected survival \<3 months
3. Chest infection, chylothorax, pleurodesis or ipsilateral lung surgery once
4. Planned chemotherapy
5. Pregnancy or breast-feeding (women of child-bearing potential)
6. Not signed informed consent or non-compliance with treatment protocols

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No