Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-28 @ 3:52 AM
Study NCT ID:
NCT01631357
Status:
COMPLETED
Last Update Posted:
2019-11-05
First Post:
2012-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Chemotherapy Combination With Autologous Cytokine-Induced Killer Cell Immunotherapy to Treat Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-31', 'studyFirstSubmitDate': '2012-05-27', 'studyFirstSubmitQcDate': '2012-06-27', 'lastUpdatePostDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'up to 3 years', 'description': 'PFS was measured from the date of randomization to the first disease progression or to death from any cause, whichever occurred first.'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'up to 3 years', 'description': 'OS was measured from the date of randomization until death from any cause.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-small Cell Lung Cancer', 'Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '1. Phase II/III study,\n2. Randomized, multicenter, open-label study,\n3. 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sex: male or female\n* Age: from 18 to 80 years\n* Histology: squamous non-small-cell lung cancer\n* Clinical stage: from stage IIIb to stage IV\n* Therapy: not received chemotherapy, radiotherapy, or immunotherapy before entry into this study\n* Karnofsky performance status: more than 50%\n* Expected survival: more than 2 months\n* Laboratory tests results 7 days before the start of treatment:\n\nWhite 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\n\n* pregnancy test: the test of women of child-bearing period must be negative 7 days before the start of treatment\n* 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\n* Informed consent: subject must have the ability to understand and voluntarily sign a written informed consent\n\nExclusion Criteria:\n\n* History of neoplasms: other neoplasms\n* Medical history: mental disease, or congestive heart failure, or severe coronary artery disease, or cardiac arrhythmias, or concomitant corticosteroid therapy\n* History of allergies: allergic to the study drugs\n* Metastasis: clinical symptoms of brain metastasis\n* Other clinical trial: the subject received other clinical trial before this study\n* Laboratory tests: the serum test of human immunodeficiency virus, or hepatitis B virus, or hepatitis C virus was positive\n* Woman: pregnant or lactating women\n* Compliance: poor compliance\n* History of neoplasms: other neoplasms'}, 'identificationModule': {'nctId': 'NCT01631357', 'acronym': 'CIK', 'briefTitle': 'Study of Chemotherapy Combination With Autologous Cytokine-Induced Killer Cell Immunotherapy to Treat Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University Cancer Institute and Hospital'}, 'officialTitle': 'Phase II/III Study of Chemotherapy Combination With Autologous Cytokine-Induced Killer Cell Immunotherapy in Stage IIIb-IV Squamous Non-Small-Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'CIH-RXB-201205001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: CIK+CT', 'description': 'Arm 1: We design chemotherapy combination with CIK cell immunotherapy as a experimential arm.', 'interventionNames': ['Biological: CIK cell', 'Drug: Gemcitabine Injection', 'Drug: Cisplatin injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2: CT', 'description': 'Arm 2: We design chemotherapy alone as a control arm', 'interventionNames': ['Drug: Gemcitabine Injection', 'Drug: Cisplatin injection']}], 'interventions': [{'name': 'CIK cell', 'type': 'BIOLOGICAL', 'otherNames': ['Cytokine-induced killer cell'], 'description': 'CIK cell injection', 'armGroupLabels': ['Arm 1: CIK+CT']}, {'name': 'Gemcitabine Injection', 'type': 'DRUG', 'otherNames': ['Gemcitabine'], 'description': 'Gemcitabine injection', 'armGroupLabels': ['Arm 1: CIK+CT', 'Arm 2: CT']}, {'name': 'Cisplatin injection', 'type': 'DRUG', 'otherNames': ['Cisplatin'], 'description': 'Cisplatin injection', 'armGroupLabels': ['Arm 1: CIK+CT', 'Arm 2: CT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300060', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Medical University Cancer Institute and Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'overallOfficials': [{'name': 'Xiubao Ren, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Tianjin Medical University Cancer Institute and Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University Cancer Institute and Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}