Study of Chemotherapy Combination With Autologous Cytokine-Induced Killer Cell Immunotherapy to Treat Lung Cancer
NCT ID: NCT01631357
Last Updated: 2019-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
96 participants
INTERVENTIONAL
2014-12-31
2018-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1: CIK+CT
Arm 1: We design chemotherapy combination with CIK cell immunotherapy as a experimential arm.
CIK cell
CIK cell injection
Gemcitabine Injection
Gemcitabine injection
Cisplatin injection
Cisplatin injection
Arm 2: CT
Arm 2: We design chemotherapy alone as a control arm
Gemcitabine Injection
Gemcitabine injection
Cisplatin injection
Cisplatin injection
Interventions
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CIK cell
CIK cell injection
Gemcitabine Injection
Gemcitabine injection
Cisplatin injection
Cisplatin injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Tianjin Medical University Cancer Institute and Hospital
OTHER
Responsible Party
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Principal Investigators
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Xiubao Ren, MD, PhD
Role: STUDY_CHAIR
Tianjin Medical University Cancer Institute and Hospital
Locations
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Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Countries
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Other Identifiers
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CIH-RXB-201205001
Identifier Type: -
Identifier Source: org_study_id
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