Phase II/III Study of Chemotherapy Combination With Autologous Cytokine-Induced Killer Cell Immunotherapy in Stage IIIb-IV Squamous Non-Small-Cell Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- CIK cell
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Progression-free survival
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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
Investigators
Eligibility Criteria
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
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
Arms & Interventions
Arm 1: CIK+CT
Arm 1: We design chemotherapy combination with CIK cell immunotherapy as a experimential arm.
Intervention: CIK cell
Arm 1: CIK+CT
Arm 1: We design chemotherapy combination with CIK cell immunotherapy as a experimential arm.
Intervention: Gemcitabine Injection
Arm 1: CIK+CT
Arm 1: We design chemotherapy combination with CIK cell immunotherapy as a experimential arm.
Intervention: Cisplatin injection
Arm 2: CT
Arm 2: We design chemotherapy alone as a control arm
Intervention: Gemcitabine Injection
Arm 2: CT
Arm 2: We design chemotherapy alone as a control arm
Intervention: Cisplatin injection
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: 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 Outcomes
- Overall survival(up to 3 years)