Intrapleural Bevacizumab Injection for Malignant Effusion in Lung Cancer

Phase 2

Completed

• Conditions: Non-small Cell Lung Cancer; Malignant Pleural Effusion
• Interventions: Drug: Bevacizumab

• Registration Number: NCT02054052
• Lead Sponsor: Haihong Yang, MD, Pricipal investigator

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

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-27
• Study First Submitted QC: 2014-02-01
• Study First Posted: 2014-02-04
• Status Verified: 2019-03
• Primary Completion: 2019-03
• Study Completion: 2019-03
• Last Update Submitted: 2019-03-27
• Last Update Posted: 2019-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Lung cancer symptom	Evaluated by lung cancer symptom scale 21-30 days after the treatment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The First Affliliated Hospital of Guangzhou MC; 🇨🇳 Guangzhou, Guangdong, China