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

Tang-Du Hospital

Status and phase: Unknown; Phase 2

Conditions: Malignant Pleural Effusion

Treatments: Drug: Bevacizumab; Drug: Pulvis talci

Study type: Interventional

Funder types: Other

Identifiers

NCT02054078

CTSL002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 183 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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183 participants in 2 patient groups

Bevacizumab

Experimental group

Description:

Bevacizumab200mg by intrapleural administration

Treatment:

Drug: Bevacizumab

Pulvis talci

Active Comparator group

Description:

Pulvis talci 4g by intrapleural administration

Treatment:

Drug: Pulvis talci