Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-01-04 @ 1:30 PM
Study NCT ID:
NCT02487992
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2016-02-24
First Post:
2015-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Study of CIK Plus S-1 and Bevacizumab as Maintenance Treatment for Patients With Advanced Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2045-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-02-23', 'studyFirstSubmitDate': '2015-06-30', 'studyFirstSubmitQcDate': '2015-06-30', 'lastUpdatePostDateStruct': {'date': '2016-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2043-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse events', 'timeFrame': '1 months'}], 'primaryOutcomes': [{'measure': 'Overall Survival(OS)', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Colorectal Neoplasms']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of cytokine-induced killer cell (CIK) plus S-1 and Bevacizumab vs S-1 and Bevacizumab as Maintenance Treatment for patients with advanced colorectal cancer.', 'detailedDescription': '1200 patients with stage Ⅳ colorectal cancer,who had received surgery and chemotherapy,will be randomly divided into group A（receive CIK plus S-1 and Bevacizumab ) or group B（just receive S-1 and Bevacizumab),and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of CIK treatment (every 1 year) and Apatinib (continuous).Patients in group B will receive only S-1 and Bevacizumab (continuous) .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who can accept curative operations 18-70 years old\n* Histologically confirmed with colorectal cancer at stage Ⅳ\n* Patients who can accept oral drugs;\n* Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1.\n\nExclusion Criteria:\n\n* Hemoglobin\\<8.0 g/dL,White blood cell \\<3 X 10\\^9/L;Platelet count \\<75 X 10\\^9/L; alanine aminotransferase, glutamic-oxalacetic transaminase, blood urine nitrogen and creatinine more than normal limits on 3.0 times\n* Known or suspected allergy to the investigational agent or any agent given in association with this trial\n* Pregnant or lactating patients\n* Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection\n* Patients who are suffering from serious autoimmune disease\n* Patients who had used long time or are using immunosuppressant\n* Patients who had active infection\n* Patients who are suffering from serious organ dysfunction\n* Patients who are suffering from other cancer\n* Other situations that the researchers considered unsuitable for this study.'}, 'identificationModule': {'nctId': 'NCT02487992', 'briefTitle': 'The Study of CIK Plus S-1 and Bevacizumab as Maintenance Treatment for Patients With Advanced Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': "The First People's Hospital of Changzhou"}, 'officialTitle': 'The Randomized, Controlled, Multicenter Clinical Trial of CIK Plus S-1 and Bevacizumab as Maintenance Treatment for Patients With Advanced Colorectal Cancer', 'orgStudyIdInfo': {'id': 'CZYY-CRC-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CIK plus S-1 and Bevacizumab', 'description': 'Cytokine-Induced Killer Cells are used to treat advanced colorectal cancer patients with S-1 and Bevacizumab.\n\nS-1, 60mg,p.o.,Bid,d2-15. Bevacizumab (Avastin),7.5mg/kg,ivgtt,d1. 3 weeks is a cycle. Continue until the disease progress.\n\nCytokine-induced killer cells 3 cycles,every 1 year. Continue until the disease progress.', 'interventionNames': ['Biological: Cytokine-Induced Killer Cells']}, {'type': 'NO_INTERVENTION', 'label': 'S-1 and Bevacizumab', 'description': 'S-1 is an oral anticancer agent, is a derivative of fluorouracil. Bevacizumab (Avastin) is a recombinant human monoclonal IgG1 antibody, which plays a role in the biological activity of human vascular endothelial growth factor. Bevacizumab is mainly used in the treatment of advanced colorectal cancer.\n\nS-1, 60mg,p.o.,Bid,d2-15. Bevacizumab (Avastin),7.5mg/kg,ivgtt,d1. 3 weeks is a cycle. Continue until the disease progress.'}], 'interventions': [{'name': 'Cytokine-Induced Killer Cells', 'type': 'BIOLOGICAL', 'description': 'CIK cells transfected with cytokine genes possess an improved proliferation rate and a higher cytotoxic activity as compared to regular CIK cells.', 'armGroupLabels': ['CIK plus S-1 and Bevacizumab']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "The First People's Hospital of Changzhou", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}