Status:
UNKNOWN
NK Cell-based Immunotherapy as Maintenance Therapy for Small-Cell Lung Cancer.
Lead Sponsor:
jiuwei cui
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Natural killer (NK) cells can kill a broad array of tumor cells in a non-major histocompatibility complex(MHC)-restricted manner. Adoptive transfer of NK may prolong the survival of patients with canc...
Detailed Description
The small-cell lung cancer (SCLC) is very sensitive to the standard-of-care first-line chemotherapy and/or radiotherapy, but it will ultimately progress or relapse and develop early resistance to conv...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed small cell lung cancer.
- Having completed first-line therapy in the presence of stable disease (SD), partial remission (PR) or complete remission (CR) status.
- Age ≥18 years.
- Karnofsky Performance Status (KPS) ≥80.
- Important organs:cardiac ejection fraction \>50%; Pulse Oxygen Saturation(SpO2) \>90%; creatinine (Cr) ≤ 2.5 times the normal range; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 times the normal range, total bilirubin (TBIL)≤2.0mg/dl (34.2umol/L);Hgb≥60g/L.
- Without contraindication of apheresis and cell isolation.
- Patients and their families having the willingness to participate in clinical trial with signed written informed consent.
Exclusion
- Patient having an active rheumatic immunologic disease.
- Uncontrolled bacterial, fungal or viral infection.
- human immunodeficiency virus(HIV), hepatitis B virus infection(HBV), hepatitis C virus(HCV) infection.
- History of organ transplantation and hemopoietic stem cell transplantation.
- Pregnant or lactating women.
- Patients using immunosuppressive agents within the first 3 months of the study or received glucocorticoid systemic therapy within a week prior to entry into the study.
- Patients receiving other immunotherapy after diagnosis.
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2020
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03410368
Start Date
April 1 2018
End Date
July 1 2020
Last Update
July 17 2018
Active Locations (1)
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1
the First Hospital of Jilin University
Ch’ang-ch’un, Jilin, China, 130021