Study of Chemotherapy Combination With Autologous Cytokine-Induced Killer Cell Immunotherapy to Treat Lung Cancer

Study Overview
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Brief Summary
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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
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Phase II/III study, Randomized, multicenter, open-label study, 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

Official Title
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Phase II/III Study of Chemotherapy Combination With Autologous Cytokine-Induced Killer Cell Immunotherapy in Stage IIIb-IV Squamous Non-Small-Cell Lung Cancer

Conditions
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Non-small Cell Lung Cancer, Squamous Cell Carcinoma

Intervention / Treatment
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* Biological: CIK cell
* Drug: Gemcitabine Injection
* Drug: Cisplatin injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: CIK+CT<br>Arm 1: We design chemotherapy combination with CIK cell immunotherapy as a experimential arm. | Biological: CIK cell<br>* CIK cell injection<br>* Other names: Cytokine-induced killer cell;Drug: Gemcitabine Injection<br>* Gemcitabine injection<br>* Other names: Gemcitabine;Drug: Cisplatin injection<br>* Cisplatin injection<br>* Other names: Cisplatin;|
| Active Comparator: Arm 2: CT<br>Arm 2: We design chemotherapy alone as a control arm | Drug: Gemcitabine Injection<br>* Gemcitabine injection<br>* Other names: Gemcitabine;Drug: Cisplatin injection<br>* Cisplatin injection<br>* Other names: Cisplatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | PFS was measured from the date of randomization to the first disease progression or to death from any cause, whichever occurred first. | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | OS was measured from the date of randomization until death from any cause. | up to 3 years |