Trial Information
A Phase 2,Open-label Study of Autologous Cytokine-Induced Killer Cell Transfusion Plus Chemotherapy as Adjuvant Therapy for Stage IB-IIIA Non-Small Cell Lung Cancer
Inclusion Criteria:
1. Stage IB-IIIA post-surgery NSCLC patients with histologically confirmed.
2. with an Eastern CooperativeOncology Group performance status of 0 or 1,
3. at least 18 years of age
4. adequate bone marrow reserve and organ function including calculated creatinine
clearance 45 mL/min based on the standard Cockcroft and Gault formula
5. patients had fully recovered from its acute effects.
Exclusion Criteria:
1. HIV positive
2. autoimmune disease
3. immune deficiency disorder
4. organ transplantation
5. received high dose glucocorticoid or other immune depressant within 4 weeks
6. active clinically serious infections (> grade 2 NCI-CTC version 3.0)
7. life threatening medical condition
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
the relapse rate
Outcome Time Frame:
30 months
Safety Issue:
No
Principal Investigator
Li Zhang, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Sun Yat-sen University
Authority:
China: Food and Drug Administration
Study ID:
2010014
NCT ID:
NCT01533727
Start Date:
August 2011
Completion Date:
December 2020
Related Keywords:
- Non-Small Cell Lung Cancer
- Cytokine-Induced Killer Cell
- NSCLC
- adjuvant therapy
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms