Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT03577392
Status:
UNKNOWN
Last Update Posted:
2019-04-04
First Post:
2018-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recombinant Human Endostatin in Combination With XELOX Therapy in Patient With Advanced Colorectal Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D000069287', 'term': 'Capecitabine'}], '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': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients were randomly assigned to receive either three treatment cycles of intravenous pump of recombinant human endostatin before chemotherapy.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-02', 'studyFirstSubmitDate': '2018-06-23', 'studyFirstSubmitQcDate': '2018-06-23', 'lastUpdatePostDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival', 'timeFrame': '4 years', 'description': 'Evaluate the effect of XELOX therapy with or without recombinant human endostatin on progression free survival'}], 'secondaryOutcomes': [{'measure': 'local control', 'timeFrame': '4 years', 'description': 'To describe local control and out-of-field disease progression'}, {'measure': 'Overall survival', 'timeFrame': '4 years', 'description': 'comparison to maintenance XELOX chemotherapy alone.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Quality of Life']}, 'descriptionModule': {'briefSummary': 'To study safety and efficacy of intravenous pump of recombinant human endostatin combined with XELOX-treated and also investigate the potential value of CECs level for the prediction of PD and outcomes in patients with advanced colorectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clear pathology diagnosis of stage for the Ⅳ period of advanced colorectal cancer.\n* There are at least 1 imaging examinations according to the standard of RECIST（the longest diameter is at least 10mm with spiral CT and 20mm with ordinary CT）.\n* Male or female , age 18～75\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* The patients had to have a life expectancy of at least 3 months.\n* A white blood count (WBC) greater than 3000/mm3, platelets greater than 100 000/mm3, and normal coagulation values.\n* Aspartate aminotransferase (AST) and adenosine triphosphate (ALT) values were to be less than 2.5 times the upper limit of normal;a bilirubin level of less than 25 lmol/l；a creatinine value less than 130 lmol/l.\n* Informed consent was obtained from all patients.\n\nExclusion Criteria:\n\n* Patients having a brain tumor or brain metastases, a bleeding disorder, receiving anti-coagulant therapy.\n* a history of myocardial infarction or angina pectoris in the last 6 months or uncontrolled congestive heart failure, having an active infection or receiving radio- or chemotherapy within 4 weeks before study.\n* patients with uncontrolled serious medical or psychiatric illness or having any other condition that was likely to interfere with regular follow-up.'}, 'identificationModule': {'nctId': 'NCT03577392', 'acronym': 'EXECC', 'briefTitle': 'Recombinant Human Endostatin in Combination With XELOX Therapy in Patient With Advanced Colorectal Cancer.', 'organization': {'class': 'OTHER', 'fullName': "Sichuan Provincial People's Hospital"}, 'officialTitle': 'Effect of Intravenous Pump of Recombinant Human Endostatin Combined With XELOX Chemotherapy, and a Potential Prognostic Biomarkers in Patient With Advanced Colorectal Cancer', 'orgStudyIdInfo': {'id': 'SIM-ED-1512'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'XELOX chemotherapy with recombinant human endotatin', 'description': "Patients received a triweekly treatment cycle.Oxaliplatin(130mg/m2 over 2h)was intravenously administated for at least 2h on day 1. Capecitabine(1000mg/m2 twice daily)was oral administrated from the evening of day 1 to the morning of day 15.The dose of Recombinant human endostatin on day -5 was calculated according to the patients's body surface area, to provide a CIV 7 days' dose in physiological saline to 240mL volume.", 'interventionNames': ['Drug: oxaliplatin + capecitabine (XELOX chemotherapy)', 'Drug: rebombniant human endostatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'XELOX chemotherapy without recombinant human endotatin', 'description': 'Patients received a triweekly treatment cycle.Oxaliplatin(130mg/m2 over 2h)was intravenously administated for at least 2h on day 1. Capecitabine(1000mg/m2 twice daily)was oral administrated from the evening of day 1 to the morning of day 15.', 'interventionNames': ['Drug: oxaliplatin + capecitabine (XELOX chemotherapy)']}], 'interventions': [{'name': 'oxaliplatin + capecitabine (XELOX chemotherapy)', 'type': 'DRUG', 'description': 'Oxaliplatin(130mg/m2 over 2h)was intravenously administated for at least 2h on day 1. Capecitabine(1000mg/m2 twice daily)was oral administrated from the evening of day 1 to the morning of day 15.', 'armGroupLabels': ['XELOX chemotherapy with recombinant human endotatin', 'XELOX chemotherapy without recombinant human endotatin']}, {'name': 'rebombniant human endostatin', 'type': 'DRUG', 'description': "Endostar is a recombinat human endostatin with antiangiogenic properties that has been useful in treating a wide range of cancers and shows promise for use in combination treatment for advanced colorectal cancer. The dose of Recombinant human endostatin on day -5 was calculated according to the patients's body surface area, to provide a CIV 7 days' dose in physiological saline to 240mL volume.", 'armGroupLabels': ['XELOX chemotherapy with recombinant human endotatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61007', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'ke xie, MD PhD', 'role': 'CONTACT'}, {'name': 'Xiong jingyan', 'role': 'CONTACT'}], 'facility': 'Sichuan Provincial People Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Ke Xie, MD PhD', 'role': 'CONTACT', 'email': '840246753@qq.com', 'phone': '008618981838382'}], 'overallOfficials': [{'name': 'Ke Xie, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sichuan Provincial People Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Sichuan Provincial People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Jiangsu Simcere Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Cancer Center', 'investigatorFullName': 'ming zeng, MD', 'investigatorAffiliation': "Sichuan Provincial People's Hospital"}}}}