Intrapleural Bevacizumab Injection for Malignant Effusion in Lung Cancer

March 27, 2019 updated by: Haihong Yang, MD, Pricipal investigator

Intrapleural Bevacizumab Injection for Treating Malignant Pleural or Pericardial Effusion in Non-small Cell Lung Cancer

Malignant pleural or pericardial effusion is common in lung cancer, and intrapleural drugs injection is important in the treatment. Non- cytotoxic drugs include those with a sclerosing effect that produces pleurodesis, which is easy to cause severe chest pain despite of no influence on the following chemotherapy. Tumor angiogenesis is important in producing MPE. Bevacizumab has been administrated locally in treating optic nerve sickness successfully by anti-VEGF mechanism. So we hypothesize that intrapleural bevacizumab is also effective in treating MPE.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Inclusion Criteria:

  1. Histological or cytological diagnosis of non-small cell lung cancer.
  2. Cytological diagnosis of malignant pleural or pericardial effusion (MPE)
  3. Symptomatic MPE evaluated by researchers
  4. Unsuitable for or reject systemic therapy of tumor
  5. Continuous TKI treatment after TKI-resistance
  6. Estimated survival of more than 3 months. 7.18 years or older

Exclusion Criteria:

  1. Current or recent (within 10 days prior to treatment) use the full amount of inhibition of platelet function, anticoagulants or thrombolytic therapy, which allows prophylactic anticoagulants
  2. Be allergic to bevacizumab
  3. Pregnant or lactating woman
  4. Pleural or pericardial infection

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • The First Affliliated Hospital of Guangzhou MC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histological or cytological diagnosis of non-small cell lung cancer.
  2. Cytological diagnosis of malignant pleural or pericardial effusion (MPE)
  3. Symptomatic MPE evaluated by researchers
  4. Unsuitable for or reject systemic therapy of tumor
  5. Estimated survival of more than 3 months. 6.18 years or older

Exclusion Criteria:

  1. Current or recent (within 10 days prior to treatment) use the full amount of inhibition of platelet function, anticoagulants or thrombolytic therapy, which allows prophylactic anticoagulants
  2. Be allergic to bevacizumab
  3. Pregnant or lactating woman
  4. Pleural or pericardial infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bevacizumab
Bevacizumab 100 mg, intrapleural injection treating maliganant pleural or percardial effusion
Drug: Bevacizumab
Bevacizumab 100 mg, intrapleural injection treating MPE after the drainage of MPE
Other Names:
  • Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lung cancer symptom
Time Frame: Evaluated by lung cancer symptom scale 21-30 days after the treatment
Evaluated by lung cancer symptom scale 21-30 days after the treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
response rate
Time Frame: Evaluate response rate 21-30 days after the treatment
Evaluate response rate 21-30 days after the treatment
Time to progression
Time Frame: 1 year after the treatment of MPE.
1 year after the treatment of MPE.
Overall survival
Time Frame: 1 year after the treatment of MPE
1 year after the treatment of MPE
Number of Participants with Adverse Events
Time Frame: one months after the treatment of MPE
one months after the treatment of MPE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haihong Yang, MD, Pricipal investigator

Investigators

  • Principal Investigator: Haihong Yang, MD, The first affiliated hospital of Guangzhou MC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

January 27, 2014

First Submitted That Met QC Criteria

February 1, 2014

First Posted (Estimate)

February 4, 2014

Study Record Updates

Last Update Posted (Actual)

March 29, 2019

Last Update Submitted That Met QC Criteria

March 27, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GZTO1401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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