Intrapleural Bevacizumab Injection for Malignant Effusion in Lung Cancer

Haihong Yang, MD, Pricipal investigator

Status and phase: Completed; Phase 2

Conditions: Non-small Cell Lung Cancer; Malignant Pleural Effusion

Treatments: Drug: Bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT02054052

GZTO1401

Details and patient eligibility

About

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.

Full 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

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Bevacizumab

Experimental group

Description:

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

Treatment:

Drug: Bevacizumab