Intrapleural Administration of Bevacizumab Versus Endostar for Pleural Effusions in NSCLC

This is an interventional treatment trial for Non Small Cell Lung Cancer Read More

Inclusion Criteria:

Patient who was confirmed stage IV NSCLC with malignant pleural effusion confirmed by cytology.

Males or females aged ≥18 years, < 75 years. Eastern Cooperative Oncology Group (ECOG) performance status 0-3. Life expectancy ≥12 weeks. Ability to maintain a drainage catheter. Previous intrapleural administration of chemotherapeutic drugs (preferred bleomycin) Males and females should be contraceptive during the period of the trial until 8 weeks after the last administration of the drug.

Adequate bone marrow, renal, and liver function are required. Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.

Institutional review board-approved informed consent will be obtained for every patient before initiation of any trial-specific procedure or treatment.

Exclusion Criteria:

Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).

Active thoracic cavity or systemic bleeding. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 0.

Female subjects should not be pregnant or breast-feeding. Known sensitivity to Bevacizumab or Endostar. Patients must not be on therapeutic anticoagulation with warfarin, heparin or low molecular weight heparin.

Adequate hematological function: Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L.

Adequate renal function: Serum creatinine ≤ 1.5 x ULN, or ≥ 50 ml/min. Adequate liver function :Total bilirubin £ 1.5 x upper limit of normal (ULN) and Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases.

Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.