Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT01533727
Status:
WITHDRAWN
Last Update Posted:
2013-12-09
First Post:
2012-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CIK Cell Transfusion Plus Chemotherapy as Adjuvant Therapy for Stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Few patients would like to participate ,since CIK cell transfusion was a new treatment and its efficacy was doubted.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-12-05', 'studyFirstSubmitDate': '2012-02-12', 'studyFirstSubmitQcDate': '2012-02-14', 'lastUpdatePostDateStruct': {'date': '2013-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the relapse rate', 'timeFrame': '30 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cytokine-Induced Killer Cell', 'NSCLC', 'adjuvant therapy'], 'conditions': ['Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Non - small cell lung cancer ( NSCLC ) accounts for more than 80% of lung cancer. The main treatment for early stage patients is surgical resection, but about 30% -70% patients will relapse. Postoperative chemotherapy is the major systemic treatment for surgical resection NSCLC patients. However, data show only 5-10% improvement in overall survival with systemic adjuvant chemotherapy. It is necessary to further improve the survival time of patients with lung cancer. Biological treatment is becoming a new treatment modality for Cancer following with surgery, radiotherapy and chemotherapy, and has been confirmed as an effective adjuvant treatment in comprehensive cancer treatment. Cytokine induced killer cells ( CIK) characterized as fast amplification, strong anti-cancer activity and broad anti-tumor spectrum is most widely used and thought to be the first choice for the new generation of anti-tumor adoptive immunotherapy. This Phase II study is investigating the efficacy of Autologous Cytokine-Induced Killer Cell Transfusion plus Chemotherapy as adjuvant therapy for stage IB-IIIA NSCLC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Stage IB-IIIA post-surgery NSCLC patients with histologically confirmed.\n2. with an Eastern CooperativeOncology Group performance status of 0 or 1,\n3. at least 18 years of age\n4. adequate bone marrow reserve and organ function including calculated creatinine clearance 45 mL/min based on the standard Cockcroft and Gault formula\n5. patients had fully recovered from its acute effects.\n\nExclusion Criteria:\n\n1. HIV positive\n2. autoimmune disease\n3. immune deficiency disorder\n4. organ transplantation\n5. received high dose glucocorticoid or other immune depressant within 4 weeks\n6. active clinically serious infections (\\> grade 2 NCI-CTC version 3.0)\n7. life threatening medical condition'}, 'identificationModule': {'nctId': 'NCT01533727', 'briefTitle': 'CIK Cell Transfusion Plus Chemotherapy as Adjuvant Therapy for Stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC)', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'A Phase 2,Open-label Study of Autologous Cytokine-Induced Killer Cell Transfusion Plus Chemotherapy as Adjuvant Therapy for Stage IB-IIIA Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': '2010014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Autologous CIK Transfusion plus Chemotherapy', 'interventionNames': ['Drug: Autologous CIK Transfusion plus Chemotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'chemotherapy alone', 'interventionNames': ['Drug: chemotherapy alone']}], 'interventions': [{'name': 'Autologous CIK Transfusion plus Chemotherapy', 'type': 'DRUG', 'description': 'vinorelbine 25-30mg/m2 d1, d8 q3w; DDP 75mg/m2 d1 q3w; pemetrexed 500mg/m2 d1 q3w; carboplatin AUC 5/6 q3w; CIK infusion D14 q3w', 'armGroupLabels': ['Group A']}, {'name': 'chemotherapy alone', 'type': 'DRUG', 'description': 'vinorelbine 25-30mg/m2 d1, d8 q3w; DDP 75mg/m2 d1 q3w; pemetrexed 500mg/m2 d1 q3w; carboplatin AUC 5/6 q3w;', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Li Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Li Zhang', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}