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Completed

NCT Number: NCT02054052

Intrapleural Bevacizumab Injection for Malignant Effusion in 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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Cardiovascular Diseases Heart Diseases Lung Diseases Lung Neoplasms Malignant Pleural Effusion Neoplasms Neoplasms by Site Pericardial Effusion Pleural Diseases Pleural Effusion Pleural Effusion, Malignant Pleural Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affliliated Hospital of Guangzhou MC

Guangzhou, Guangdong, 510120, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevacizumab

Drug

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

Other names: Avastin

Primary outcomes

  1. Lung cancer symptom

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

Secondary outcomes

  1. response rate

    Time frame: Evaluate response rate 21-30 days after the treatment

  2. Time to progression

    Time frame: 1 year after the treatment of MPE.

  3. Overall survival

    Time frame: 1 year after the treatment of MPE

  4. Number of Participants with Adverse Events

    Time frame: one months after the treatment of MPE

Sponsors and collaborators

Lead sponsor

Haihong Yang, MD, Pricipal investigator

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Feb 4, 2014
Registry last updated
Mar 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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