Phase II/III Study of Chemotherapy Combination With Autologous Cytokine-Induced Killer Cell Immunotherapy in Stage IIIb-IV Squamous Non-Small-Cell Lung Cancer
Inclusion Criteria:
- Sex: male or female
- Age: from 18 to 80 years
- Histology: squamous non-small-cell lung cancer
- Clinical stage: from stage IIIb to stage IV
- Therapy: not received chemotherapy, radiotherapy, or immunotherapy before entry into
this study
- Karnofsky performance status: more than 50%
- Expected survival: more than 2 months
- Laboratory tests results 7 days before the start of treatment:
White blood cells: more than 3.0 × 109/L Platelets: more than 100 × 109/L Neutrophils:
more than 1.5 × 109/L Hemoglobin: more than 80g/L Serum glutamate pyruvate transaminase:
less than 2.5 folds of the upper normal limit (ULN) Serum glutamic-oxal (o)
acetic transaminase: less than 2.5 × ULN Serum bilirubin: less than 1.25 × ULN Serum
creatinine: less than 1.25 × ULN
- pregnancy test: the test of women of child-bearing period must be negative 7 days
before the start of treatment
- Contraception: male and female subjects of child-bearing period must adopt a reliable
method of contraception before entry into this study until 30 days after stopping
this study
- Informed consent: subject must have the ability to understand and voluntarily sign a
written informed consent
Exclusion Criteria:
- History of neoplasms: other neoplasms
- Medical history: mental disease, or congestive heart failure, or severe coronary
artery disease, or cardiac arrhythmias, or concomitant corticosteroid therapy
- History of allergies: allergic to the study drugs
- Metastasis: clinical symptoms of brain metastasis
- Other clinical trial: the subject received other clinical trial before this study
- Laboratory tests: the serum test of human immunodeficiency virus, or hepatitis B
virus, or hepatitis C virus was positive
- Woman: pregnant or lactating women
- Compliance: poor compliance
- History of neoplasms: other neoplasms