Non-small Cell Lung Cancer, Squamous Cell Carcinoma
Conditions
Brief summary
This randomized, multicenter,open-label phase II/III study is to evaluate the effects of chemotherapy combination with autologous cytokine-induced killer Cell immunotherapy in patients with stage IIIb-IV squamous non-small-cell lung cancer
Detailed description
1. Phase II/III study, 2. Randomized, multicenter, open-label study, 3. Evaluated the effects of chemotherapy combination with autologous cytokine-induced killer Cell immunotherapy compared with chemotherapy in patients with stage IIIb-IV squamous non-small-cell lung cancer
Interventions
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | up to 3 years | PFS was measured from the date of randomization to the first disease progression or to death from any cause, whichever occurred first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | up to 3 years | OS was measured from the date of randomization until death from any cause. |
Countries
China
Outcome results
None listed