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

Phase 2

• Conditions: Malignant Pleural Effusion
• Interventions: Drug: Bevacizumab; Drug: Pulvis talci

• Registration Number: NCT02054078
• Lead Sponsor: Tang-Du Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2014-01-28
• Status Verified: 2014-02
• Study First Submitted QC: 2014-02-03
• Last Update Submitted: 2014-02-03
• Study First Posted: 2014-02-04
• Last Update Posted: 2014-02-04
• Primary Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 183

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bevacizumab	Bevacizumab	Bevacizumab200mg by intrapleural administration
Pulvis talci	Pulvis talci	Pulvis talci 4g by intrapleural administration

Primary Outcome Measures

Name	Time	Method
Changes in chest drainage	up to 3months	Observed chest drainage every day

Secondary Outcome Measures

Name	Time	Method
the average daily VAS defining breathlessness	up to 1 year	VAS: Visual Analogue Scale
Average daily thoracalgia assessed using VAS score	up to 1 year	VAS: Visual Analogue Scale
percentage of adverse reactions	up to 1 year
Length of Stay	up to 1 year

Trial Locations

Locations (1)

Tangdu Hospital; 🇨🇳 Xi'an, Shaanxi, China