Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-02-22 @ 11:10 AM
Study NCT ID:
NCT02665702
Status:
UNKNOWN
Last Update Posted:
2016-01-28
First Post:
2016-01-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endostar Combined With NVB and DDP Second-line Treatment of Advanced Esophageal Squamous Cell Carcinomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077277', 'term': 'Esophageal Squamous Cell Carcinoma'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077235', 'term': 'Vinorelbine'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'C522911', 'term': 'endostar protein'}], 'ancestors': [{'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-01-24', 'studyFirstSubmitDate': '2016-01-19', 'studyFirstSubmitQcDate': '2016-01-24', 'lastUpdatePostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': 'from the first cycle of treatment (day one) to two month after the last cycle'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Esophageal Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to explore whether endostar combined with NVB and DDP as treatment could improve progression-free surial time (PFS) and to evaluate the safety of the chemotherapy regimens', 'detailedDescription': 'This study is to explore whether endostar combined with NVB and DDP as treatment could improve progression-free surial time (PFS) and to evaluate the safety of the chemotherapy regimens used as second-line treatment of advanced esophageal squamous cell carcinomas'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Histologically proven primary thoracic esophageal squamous cell carcinoma\n2. According to the esophageal AJCC2009 7th to determine new stage IV esophageal cancer\n3. The subject has PD after first-line chemotherapy or radiation within a year\n4. Presence of at least one index lesion measurable by CT scan or MRI according to RECIST 1.1\n5. Can eat more than liquid diet; No signs before esophageal perforation\n6. 18\\~75 years\n7. PS:0-1\n8. Life expectancy of ≥ 3 months\n9. ANC ≥ 2×109/L，PLT ≥ 100×109/L，Hb ≥ 90g/L\n10. TB ≤ UNL； ALT/AST ≤ 2.5×UNL，AKP ≤ 5×UNL\n11. Ccr≤ UNL,Scr≥60 mL/min\n12. Normal electrocardiogram (ecg), the body had no unheal wounds\n13. Radiotherapy before within the scope of the normal dose and not affect subsequent treatment\n14. Prior to biological agents, especially e. coli genetically engineered products without severe allergic reactions\n15. Signed written informed consent\n\nExclusion Criteria:\n\n1. Breast-feeding or pregnant women, no effective contraception if risk of conception exists\n2. Chronic diarrhea, enteritis, intestine obstruction which are not under control\n3. Esophageal obstruction cannot eat liquid completely, esophagus have deep ulcer perforation or hematemesis; Esophageal cancer common complications such as anastomotic leakage, serious lung complications, etc.\n4. A second primary tumor (except skin basal cell carcinoma)\n5. The original serious heart disease, including: higher risk of congestive heart failure, unable to control arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension\n6. With uncontrol nerve, mental illness or mental disorders, compliance is poor, can't cooperate with accounts and response to treatment; Primary brain tumors or CNS metastases illness did not get a control, has obvious cranial hypertension or nerve mental symptoms\n7. With bleeding tendency\n8. Has inherited bleeding evidence of physical or blood coagulation disorder\n9. With clear chemotherapy drug allergy\n10. Other researchers believe that patients should not participate in this testing"}, 'identificationModule': {'nctId': 'NCT02665702', 'briefTitle': 'Endostar Combined With NVB and DDP Second-line Treatment of Advanced Esophageal Squamous Cell Carcinomas', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Endostar Combined With NVB and DDP Second-line Treatment of Advanced Esophageal Squamous Cell Carcinomas of the Prospective, Single Arm Phase II Clinical Study', 'orgStudyIdInfo': {'id': 'ENDO-SH-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endostar Combined With NVB and DDP', 'description': 'Endostar15mg/m2 NVB25 mg/m2 DDP75 mg/m2', 'interventionNames': ['Drug: NVB', 'Drug: DDP', 'Drug: Endostar']}], 'interventions': [{'name': 'NVB', 'type': 'DRUG', 'otherNames': ['Vinorelbine Injection'], 'description': '25mg/m2 ，D1，8', 'armGroupLabels': ['Endostar Combined With NVB and DDP']}, {'name': 'DDP', 'type': 'DRUG', 'otherNames': ['Cisplatin'], 'description': '75mg/m2 ，D1 or 25mg/m2 D1-3', 'armGroupLabels': ['Endostar Combined With NVB and DDP']}, {'name': 'Endostar', 'type': 'DRUG', 'otherNames': ['endo'], 'description': '15mg/d，d1-d7 civ', 'armGroupLabels': ['Endostar Combined With NVB and DDP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chang jian hua, PD', 'role': 'CONTACT', 'email': 'changjianhua@163.com', 'phone': '13916619284'}], 'facility': 'Cancer hospital Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Chang jian Hua, PD', 'role': 'CONTACT', 'email': 'changjianhua@163.com', 'phone': '13916619284'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Chang Jian Hua', 'investigatorAffiliation': 'Fudan University'}}}}