Efficacy and Safety of Bevacizumab Versus Pulvis Talci in Malignant Pleural Effusion
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02054078 |
Recruitment Status : Unknown
Verified February 2014 by Xiaofei Li, Tang-Du Hospital.
Recruitment status was: Recruiting
First Posted : February 4, 2014
Last Update Posted : February 4, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Malignant Pleural Effusion | Drug: Bevacizumab Drug: Pulvis talci | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 183 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Efficacy and Safety of Intrapleural Bevacizumab Versus Pulvis Talci in Malignant Pleural Effusion, A Randomized, Multicenter Study |
Study Start Date : | January 2012 |
Estimated Primary Completion Date : | March 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Bevacizumab
Bevacizumab200mg by intrapleural administration
|
Drug: Bevacizumab
Bevacizumab200mg by intrapleural administration
Other Name: Avastin |
Active Comparator: Pulvis talci
Pulvis talci 4g by intrapleural administration
|
Drug: Pulvis talci
Pulvis talci 4g by intrapleural administration |
- Changes in chest drainage [ Time Frame: up to 3months ]Observed chest drainage every day
- the average daily VAS defining breathlessness [ Time Frame: up to 1 year ]VAS: Visual Analogue Scale
- Average daily thoracalgia assessed using VAS score [ Time Frame: up to 1 year ]VAS: Visual Analogue Scale
- percentage of adverse reactions [ Time Frame: up to 1 year ]
- Length of Stay [ Time Frame: up to 1 year ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02054078
Contact: xiaofei li, doctor | 13909111010 | lxfchest@fmmu.edu.cn |
China, Shaanxi | |
Tangdu Hospital | Recruiting |
Xi'an, Shaanxi, China | |
Contact: qiang lu, doctor 18092920605 luqiang@fmmu.edu.cn |
Responsible Party: | Xiaofei Li, chief physician, Tang-Du Hospital |
ClinicalTrials.gov Identifier: | NCT02054078 |
Other Study ID Numbers: |
CTSL002 |
First Posted: | February 4, 2014 Key Record Dates |
Last Update Posted: | February 4, 2014 |
Last Verified: | February 2014 |
Pleural Effusion, Malignant Pleural Effusion Pleural Diseases Respiratory Tract Diseases Pleural Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms |
Bevacizumab Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |