Study of Chemotherapy Combination With Autologous Cytokine-Induced Killer Cell Immunotherapy to Treat Lung Cancer
- Conditions
- Non-small Cell Lung CancerSquamous Cell Carcinoma
- Interventions
- Registration Number
- NCT01631357
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2: CT Gemcitabine Injection Arm 2: We design chemotherapy alone as a control arm Arm 2: CT Cisplatin injection Arm 2: We design chemotherapy alone as a control arm Arm 1: CIK+CT CIK cell Arm 1: We design chemotherapy combination with CIK cell immunotherapy as a experimential arm. Arm 1: CIK+CT Gemcitabine Injection Arm 1: We design chemotherapy combination with CIK cell immunotherapy as a experimential arm. Arm 1: CIK+CT Cisplatin injection Arm 1: We design chemotherapy combination with CIK cell immunotherapy as a experimential arm.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Overall survival up to 3 years OS was measured from the date of randomization until death from any cause.
Trial Locations
- Locations (1)
Tianjin Medical University Cancer Institute and Hospital
🇨🇳Tianjin, Tianjin, China