Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-01-29 @ 4:28 PM
Study NCT ID:
NCT03706703
Status:
UNKNOWN
Last Update Posted:
2018-10-17
First Post:
2018-10-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rh-Endostatin (Endostar®) Continuous Intravenous Infusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'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': 'C522911', 'term': 'endostar protein'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D000068437', 'term': 'Pemetrexed'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-15', 'studyFirstSubmitDate': '2018-10-09', 'studyFirstSubmitQcDate': '2018-10-11', 'lastUpdatePostDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ORR', 'timeFrame': '8 weeks', 'description': 'objective response rate based on Recist 1.1 edition'}], 'secondaryOutcomes': [{'measure': 'PFS', 'timeFrame': '8 weeks', 'description': 'progress free survival'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Endostar is a anti-angiogenesis product and has been launched in China . The efficacy and safety have been defined. However, the compliance is unsatisfactory since routine i.v of Endostar is needed for 3 to 4 hours daily during one cycle of 14 days. The continuous intravenous infusion by using venous pump can improve the compliance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nPrimary non-small cell lung cancer confirmed by cytology and histology, excluding sputum examination;\n\nPhase IIIB/IV based on TNM criteria (8th);\n\nAt least one measurable tumor based on RECIST 1.1;\n\nWithout the known active mutation of EGFR/ALK/ROS1/RET;\n\nMale or female, age≥18 or ≤70 years old;\n\nECOG PS: 0 or 1;\n\nEstimated time of survival: ≥ 3 months;\n\nSuitable hematologic function: ANC≥2×109/L, PLC≥100×109/L and Hb≥9 g/dL;\n\nSuitable liver function: Total bilirubin≤ normal ULN, AST and ALT≤2.5×normal ULN, ALP≤ 5×normal ULN;\n\nSuitable renal function: Cr≤normal ULN,or Ccr≥60 ml/min;\n\nEKG normal;\n\nWithout healing wound;\n\nNo history of anti-cancer therapy, or adjuvant/neo-adjuvant chemotherapy for non-metastatic tumor finished for more than 6 months before enrollment;\n\nFor the female subject with productive ability, urine pregnancy test must be done and is negative within 7 days before enrollment;\n\nNo history of serious allergic to biologic agents, especially E.Coli products;\n\nThe authorized ICF must be signed.\n\nExclusion Criteria:\n\nWoman in pregnancy and breast-feeding, or having productive ability without contraception;\n\nHaving the serious acute infection uncontrolled or purulent/chronic infection with unhealed wound;\n\nHaving the serious heart disease, including congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina, myocardial infarction, valvular disease, and refractory hypertension;\n\nHaving uncontrolled nervous or mental disease with low compliance and reluctance to description of response; uncontrolled primary brain tumor or other metastatic brain cancer with obvious intracranial hypertension or mental symptoms;\n\nHaving the tendency of bleeding, such as FIB≤2G/L;\n\nBeing receiving adjuvant chemotherapy;\n\nOn other conditions investigator considers, the subject is not fitful to participate the trial.'}, 'identificationModule': {'nctId': 'NCT03706703', 'briefTitle': 'Rh-Endostatin (Endostar®) Continuous Intravenous Infusion', 'organization': {'class': 'OTHER', 'fullName': 'Affiliated Cancer Hospital & Institute of Guangzhou Medical University'}, 'officialTitle': 'The Safety and Efficacy of Rh-Endostatin (Endostar®) Continuous Intravenous Infusion in Combination With Docetaxel/Carboplatin or Pemetrexed/Carboplatin (DC/PC) Regimens for Untreated Stage IIIB/IV Non-small-cell Lung Cancer (NSCLC)', 'orgStudyIdInfo': {'id': 'ENDOSTAR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endostar continuous intravenous infusion', 'description': 'Endostar continuous intravenous infusion in combination with docetaxel/carboplatin or pemetrexed/carboplatin', 'interventionNames': ['Drug: Endostar', 'Drug: Docetaxel', 'Drug: Carboplatin', 'Drug: Pemetrexed']}], 'interventions': [{'name': 'Endostar', 'type': 'DRUG', 'description': 'continuous intravenous infusion Endostar,7.5mg/m2, continuous intravenous infusion for 14 days each cycle, 21 days as one cycle, 4 cycles in total.', 'armGroupLabels': ['Endostar continuous intravenous infusion']}, {'name': 'Docetaxel', 'type': 'DRUG', 'description': 'docetaxel is 75 mg/m2 intravenously over 1 hour on Day 1 of each 21-day cycle', 'armGroupLabels': ['Endostar continuous intravenous infusion']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'carboplatin is administered on Day 1 of each 21-day，followed by docetaxol or pemetrexed', 'armGroupLabels': ['Endostar continuous intravenous infusion']}, {'name': 'Pemetrexed', 'type': 'DRUG', 'description': 'pemetrexed is 500 mg/m2 intravenously on Days 1 of each 21-day cycle', 'armGroupLabels': ['Endostar continuous intravenous infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chuan Jin, post-graduate', 'role': 'CONTACT', 'email': '18302078099@163.com', 'phone': '020-66673666'}], 'facility': 'Affiliated Cancer Hospital & Institute of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Affiliated Cancer Hospital & Institute of Guangzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}