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

Sponsor
Tang-Du Hospital
Study ID
NCT02054078
Phase
PHASE2
Status
Unknown

Conditions

  • Malignant Pleural Effusion

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    Bevacizumab200mg by intrapleural administration
  • Pulvis talci — DRUG
    Pulvis talci 4g by intrapleural administration

Study Details

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.

Key Dates

First listed
Feb 4, 2014
Start date
Jan 31, 2012
Status verified
Feb 2014
Primary completion
Mar 31, 2014

Study Design

Enrollment
183 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab
    Bevacizumab200mg by intrapleural administration
  • Active Comparator: Pulvis talci
    Pulvis talci 4g by intrapleural administration

Primary Outcome Measure

Changes in chest drainage [ Time Frame: up to 3months ]

Central Contacts

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