Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-02-27 @ 4:33 PM
Study NCT ID:
NCT01679327
Status:
UNKNOWN
Last Update Posted:
2012-09-06
First Post:
2012-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Bevacizumab Plus Chemotherapy in Patients With Metastatic 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2014-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-09-05', 'studyFirstSubmitDate': '2012-08-18', 'studyFirstSubmitQcDate': '2012-09-05', 'lastUpdatePostDateStruct': {'date': '2012-09-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': '36 months', 'description': 'During the chemotherapy,all the patients demonstrate CT scan or MR to evaluate tumor response to therapy every two cycles.According to RECIST 1.1,tumor response was recorded.'}], 'secondaryOutcomes': [{'measure': 'progression free survival', 'timeFrame': '36 months', 'description': 'The start time point was defined as when patients receive the first cycle chemotherapy.The end time point was defined as When tumor response to therapy was evaluated as PD according to RECIST 1.1 or patients die for any reason.'}, {'measure': 'overall survival', 'timeFrame': '36 months', 'description': 'From the time patients receive the first cycle chemotherapy to the time they die for any reason.'}, {'measure': 'Number of Participants with Adverse Events', 'timeFrame': '36 months', 'description': 'Every cycle we demonstrate routine blood test,routine urine test,routine stool test,blood biochemical test.We recommend patients take blood pressure at least twice a week during the therapy.If needed,patients also need have electrocardiogram test and echocardiography.We will evaluate the toxicity according to CTCAE4.0'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'This study evaluates the relationship of biomarker expression and efficacy of bevacizumab plus chemotherapy in patients with unresectable/metastatic colorectal cancer. Before the treatment, the investigators detect the VEGF-A,VEGF-C,VEGF-D,VEGFR-1,VEGFR-2,VEGFR-3 expression in tumor tissue by IHC and detect those protein expression level in plasma by ELISA. After at least 6 weeks treatment, the investigators detect again VEGF-A,VEGF-C,VEGF-D expression level in plasma by ELISA. The aim of the study is to identify whether those biomarkers could predict Bevacizumab efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* More than 18-years old,male or female\n* Pathologically approved as unresectable/metastatic colorectal cancer\n* KPS \\> 70% or ECOG 0-2\n* HGB \\> 80 g/L, NEUT ≥ 1.5x109 /L, PLT ≥ 80x109 /L; CR \\< 1.5 x Upper normality，\n* TB \\< 1.5 X Upper normality，AST or ALT \\< 2.5 x Upper normality.\n* Signed consent\n\nExclusion Criteria:\n\n* Other malignancies simultaneously except in situ cervix or nonmelanoma skin cancer\n* Pregnancy or in lactation\n* HGB \\< 80 g/L, NEUT \\< 1.5x109 /L, PLT \\< 80x109 /L; CR ≥ 1.5 x Upper normality， TB ≥ 2.5 X Upper normality，AST or ALT ≥2.5 x Upper normality，AKP ≥ 2.5 X Upper normality'}, 'identificationModule': {'nctId': 'NCT01679327', 'briefTitle': 'Study of Bevacizumab Plus Chemotherapy in Patients With Metastatic Colorectal Cancer', 'organization': {'class': 'UNKNOWN', 'fullName': 'ChineseAMS'}, 'officialTitle': 'Study of Bevacizumab Plus Chemotherapy in Patients With Metastatic Colorectal Cancer', 'orgStudyIdInfo': {'id': 'WY0524'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bevacizumab plus chemotherapy（XELOX or FOLFOX）', 'description': 'Bevacizumab plus XELOX (Bevacizumab 7.5mg/kg d1;Xeloda 2g/m2 d1-14 divided into two times;Oxaliplatin 130mg/m2 d1;repeated in 21 days) Bevacizumab plus FOLFOX (Oxaliplatin 85mg/ m2 ivgtt d1;CF 200mg/ m2 ivgtt d1;Bevacizumab 5mg/kg ivgtt d1 5-FU 400mg /m2 ivgtt d1;5-FU 2400mg/m2 CIV 48h;repeated in 14 days)', 'interventionNames': ['Drug: Oxaliplatin', 'Drug: Xeloda', 'Drug: Calcium folinate (CF)', 'Drug: 5-FU', 'Drug: Bevacizumab']}], 'interventions': [{'name': 'Oxaliplatin', 'type': 'DRUG', 'otherNames': ['Eloxatin'], 'armGroupLabels': ['Bevacizumab plus chemotherapy（XELOX or FOLFOX）']}, {'name': 'Xeloda', 'type': 'DRUG', 'otherNames': ['Capetabine'], 'armGroupLabels': ['Bevacizumab plus chemotherapy（XELOX or FOLFOX）']}, {'name': 'Calcium folinate (CF)', 'type': 'DRUG', 'otherNames': ['Calcium folinate'], 'armGroupLabels': ['Bevacizumab plus chemotherapy（XELOX or FOLFOX）']}, {'name': '5-FU', 'type': 'DRUG', 'armGroupLabels': ['Bevacizumab plus chemotherapy（XELOX or FOLFOX）']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'otherNames': ['Avastin'], 'armGroupLabels': ['Bevacizumab plus chemotherapy（XELOX or FOLFOX）']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yihebali Chi, MD', 'role': 'CONTACT', 'email': 'Yihebalichi@yahoo.com', 'phone': '8610-87788145'}], 'facility': 'Cancer Institute&Hospital Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Yihebali Chi, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese Academy of Medical Sciences'}, {'name': 'Jinwan WANG', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chinese Academy of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associated professor', 'investigatorFullName': 'yihebali chi', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences'}}}}