Intrapleural Administration of Bevacizumab Versus Endostar for Pleural Effusions in NSCLC
NCT ID: NCT02005120
Last Updated: 2013-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
20 participants
INTERVENTIONAL
2013-12-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Bevacizumab
Bevacizumab
Intrapleural administration of bevacizumab
Arm B
recombinant human endostatin
recombinant human endostatin
Intrapleural administration of recombinant human endostatin
Interventions
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Bevacizumab
Intrapleural administration of bevacizumab
recombinant human endostatin
Intrapleural administration of recombinant human endostatin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Zhejiang University
OTHER
Responsible Party
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Qiong Zhao
Chief of Department of Thoracic Oncology
Principal Investigators
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Qiong Zhao, PhD
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital, Zhejiang University
Locations
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Qiong Zhao
Hangzhou, Zhejiang, China
The first affiliated hospital, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Qiong Zhao, PhD
Role: primary
Qiong Zhao, PhD
Role: primary
Other Identifiers
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ZhejiangUniv
Identifier Type: -
Identifier Source: org_study_id