Status:
UNKNOWN
The Combination of Apatinib and Camerlizumab for Advanced Lung Cancer Patients With Muti-line Therapy
Lead Sponsor:
The Affiliated Hospital of Qingdao University
Conditions:
Lung Cancer
Eligibility:
All Genders
18-90 years
Brief Summary
The combination of Apatinib and Camrelizumab for progressed NSCLC patients with muti-line therapy : a phaseⅠB clinical study. Brief Summary: Immunotherapy has made a major progress in Lung cancer.How...
Detailed Description
Enrolled patients received apatinib plus Camrelizumab treatment (apatinib, 250mg, qd; Camrelizumab, 5mg/kg, iv, d1, 21day as a cycle.)
Eligibility Criteria
Inclusion
- Clinical diagnosis of Lung cancer Ability to comply with protocol Aged ≥ 18 years Histologically documented NSCLC that is currently locally advanced or metastatic NSCLC Disease progression during or following at least one line treatment. Measurable disease, as defined by RECIST v1.1 ECOG performance status of 0 or 1 Life expectancy ≥ 12 weeks Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment: ANC ≥ 1.5 × 109/L (without granulocyte colony-stimulating factor support within 2 weeks of laboratory test used to determine eligibility) WBC counts \> 2.5 × 109/L and \< 15 × 109/L Lymphocyte count ≥ 0.5 × 109/L Serum albumin ≥ 2.5 g/dL Platelet count ≥ 100 × 109/L (without transfusion within 2 weeks of laboratory test used to determine eligibility) Hemoglobin ≥ 9.0 g/dL Patients may be transfused or receive erythropoietic treatment to meet this criterion.
- Liver function tests meeting one of the following criteria:
- AST or ALT ≤ 2.5 × upper limit of normal (ULN), with alkaline phosphatase
- ≤ 2.5 × ULN or AST and ALT ≤ 1.5 × ULN in conjunction with alkaline phosphatase \> 2.5 × ULN Serum bilirubin ≤ 1.5 × ULN Patients with known Gilbert's disease who have serum bilirubin level ≤ 3 × ULN may be enrolled. INR and aPTT ≤ 1.5 × ULN This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose for at least 1 week prior to randomization. Creatinine clearance ≥ 30 mL/min Cockcroft-Gault, Chronic Kidney Disease Epidemiology Collaboration, or Modification of Diet in Renal Disease formulas may be used for creatinine clearance calculation. Note that 24-hour urine collection is not required but is allowed.
Exclusion
- Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments Leptomeningeal disease Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures Uncontrolled hypertension Perior used anti-angiogenic agents or immune checkpoint inhibitors.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04782622
Start Date
March 1 2021
End Date
March 1 2023
Last Update
March 4 2021
Active Locations (1)
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1
Xiaochun Zhang
Qingdao, None Selected, China, 266003