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Intrapleural Bevacizumab Injection for Malignant Effusion in Lung Cancer

Primary Purpose

Non-small Cell Lung Cancer, Malignant Pleural Effusion

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Bevacizumab

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring non-small cell lung cancer, malignant pleural effusion, bevacizumab, intrapleural injection, pericardial effusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
Be allergic to bevacizumab
Pregnant or lactating woman
Pleural or pericardial infection

Sites / Locations

The First Affliliated Hospital of Guangzhou MC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bevacizumab

Arm Description

Bevacizumab 100 mg, intrapleural injection treating maliganant pleural or percardial effusion

Outcomes

Primary Outcome Measures

Lung cancer symptom

Secondary Outcome Measures

response rate

Time to progression

Overall survival

Number of Participants with Adverse Events

Full Information

NCT ID

NCT02054052

First Posted

January 27, 2014

Last Updated

March 27, 2019

Sponsor

Haihong Yang, MD, Pricipal investigator

1. Study Identification

Unique Protocol Identification Number

NCT02054052

Brief Title

Intrapleural Bevacizumab Injection for Malignant Effusion in Lung Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

January 2014 (Actual)

Primary Completion Date

March 2019 (Actual)

Study Completion Date

March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Haihong Yang, MD, Pricipal investigator

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

Inclusion Criteria: Histological or cytological diagnosis of non-small cell lung cancer. Cytological diagnosis of malignant pleural or pericardial effusion (MPE) Symptomatic MPE evaluated by researchers Unsuitable for or reject systemic therapy of tumor Continuous TKI treatment after TKI-resistance Estimated survival of more than 3 months. 7.18 years or older Exclusion Criteria: 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 Be allergic to bevacizumab Pregnant or lactating woman Pleural or pericardial infection

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer, Malignant Pleural Effusion

Keywords

non-small cell lung cancer, malignant pleural effusion, bevacizumab, intrapleural injection, pericardial effusion

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bevacizumab

Arm Type

Experimental

Arm Description

Bevacizumab 100 mg, intrapleural injection treating maliganant pleural or percardial effusion

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Other Intervention Name(s)

Avastin

Intervention Description

Bevacizumab 100 mg, intrapleural injection treating MPE after the drainage of MPE

Primary Outcome Measure Information:

Title

Lung cancer symptom

Time Frame

Evaluated by lung cancer symptom scale 21-30 days after the treatment

Secondary Outcome Measure Information:

Title

response rate

Time Frame

Evaluate response rate 21-30 days after the treatment

Title

Time to progression

Time Frame

1 year after the treatment of MPE.

Title

Overall survival

Time Frame

1 year after the treatment of MPE

Title

Number of Participants with Adverse Events

Time Frame

one months after the treatment of MPE

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histological or cytological diagnosis of non-small cell lung cancer. Cytological diagnosis of malignant pleural or pericardial effusion (MPE) Symptomatic MPE evaluated by researchers Unsuitable for or reject systemic therapy of tumor Estimated survival of more than 3 months. 6.18 years or older Exclusion Criteria: 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 Be allergic to bevacizumab Pregnant or lactating woman Pleural or pericardial infection

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Haihong Yang, MD

Organizational Affiliation

the First Affiliated Hospital of Guangzhou MC

Official's Role

Principal Investigator

Facility Information:

Facility Name

The First Affliliated Hospital of Guangzhou MC

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510120

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Intrapleural Bevacizumab Injection for Malignant Effusion in Lung Cancer

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