Clinical Trial: Intrapleural Bevacizumab Injection for Malignant Effusion in Lung Cancer

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

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

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 Summary:

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

Sponsor: Haihong Yang, MD, Pricipal investigator

Current Primary Outcome: Lung cancer symptom [ Time Frame: Evaluated by lung cancer symptom scale 21-30 days after the treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • response rate [ Time Frame: Evaluate response rate 21-30 days after the treatment ]
  • Time to progression [ Time Frame: 1 year after the treatment of MPE. ]
  • Overall survival [ Time Frame: 1 year after the treatment of MPE ]
  • Number of Participants with Adverse Events [ Time Frame: one months after the treatment of MPE ]


Original Secondary Outcome: Same as current

Information By: Guangzhou Medical University

Dates:
Date Received: January 27, 2014
Date Started: January 2014
Date Completion: June 2017
Last Updated: March 1, 2017
Last Verified: March 2017