Intrapleural Bevacizumab Injection for Malignant Effusion in Lung Cancer

NCT ID: NCT02054052

Last Updated: 2019-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2019-03-31

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:

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

Conditions

Non-small Cell Lung Cancer; Malignant Pleural Effusion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bevacizumab

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

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: DRUG

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

Interventions

Bevacizumab

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

Intervention Type: DRUG

Other Intervention Names

Avastin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haihong Yang, MD, Pricipal investigator

OTHER

Sponsor Role: lead

Responsible Party

Haihong Yang, MD, Pricipal investigator

Deputy Chief Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Haihong Yang, MD

Role: PRINCIPAL_INVESTIGATOR

the First Affiliated Hospital of Guangzhou MC

Locations

The First Affliliated Hospital of Guangzhou MC

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

GZTO1401

Identifier Type: -

Identifier Source: org_study_id