Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-02-02 @ 1:42 AM
Study NCT ID:
NCT02034968
Status:
WITHDRAWN
Last Update Posted:
2015-03-05
First Post:
2014-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nimotuzumab Plus Nab-paclitaxel and Cisplatin in Treating Patients With Advanced Esophageal Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077277', 'term': 'Esophageal Squamous Cell Carcinoma'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}], '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': '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': 'C501466', 'term': 'nimotuzumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No recruitment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-04', 'studyFirstSubmitDate': '2014-01-10', 'studyFirstSubmitQcDate': '2014-01-13', 'lastUpdatePostDateStruct': {'date': '2015-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': '12 months'}, {'measure': 'Adverse events', 'timeFrame': 'During the chemotherapy,an expected average of 3 weeks', 'description': 'Adverse events were classified according to U.S. National Cancer Institute common toxicity criteria, version 4.0'}], 'primaryOutcomes': [{'measure': 'Progression free survival(PFS)', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate', 'timeFrame': 'From date of treatment until the date of progression, assessed up to 2 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nimotuzumab', 'Nab-Paclitaxel', 'Carcinoma of Esophagus'], 'conditions': ['Stage IV Esophageal Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'There have been reports suggesting that anti-epidermal growth factor antibody nimotuzumab is advantageous for advanced esophageal cancer patients in combination with chemotherapy or radiotherapy.And,albumin-bound paclitaxel was characterized with high tolerated doses with greater efficacy,and with greater concentration in tumor tissue compared with normal tissues.So,The objective of this single-arm phase II trial was to evaluate the benefit of nimotuzumab plus nab-paclitaxel and cisplatin in patients with advanced esophageal carcinoma.', 'detailedDescription': 'In the past decade, clinical trials have evaluated the role of chemotherapy, radiation, or both, for patients with advanced esophageal carcinoma, but have all failed to demonstrate a consistent survival benefit. In Eastern countries, Chemotherapy became one of the treatment strategies for advanced esophageal cancer. In an effort to improve the efficacy of systemic chemotherapy, the investigators conducted a prospective study to evaluate the regimen of Nimotuzumab plus Nab-paclitaxel/cisplatin for patients with advanced esophageal squamous cell carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient who was confirmed stage IV esophageal carcinoma by pathologic histology or cytology.\n* Males or females aged ≥18 years, \\< 75 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Life expectancy ≥12 weeks.\n* Adequate bone marrow, renal, and liver function are required.\n* Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.\n\nExclusion Criteria:\n\n* Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).\n* Allergy to anti-EGFR antibody.\n* Female subjects should not be pregnant or breast-feeding.\n* Adequate hematological function: Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L. Adequate renal function: Serum creatinine ≤ 1.5 x ULN, or ≥ 50 ml/min. Adequate liver function: total bilirubin \\< 1.5 x upper limit of normal (ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\< 2.5 x ULN in the absence of liver metastases, or \\< 5 x ULN in case of liver metastases.\n* Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.'}, 'identificationModule': {'nctId': 'NCT02034968', 'briefTitle': 'Nimotuzumab Plus Nab-paclitaxel and Cisplatin in Treating Patients With Advanced Esophageal Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Nimotuzumab Plus Nab-paclitaxel and Cisplatin in Treating Patients With Advanced Esophageal Carcinoma', 'orgStudyIdInfo': {'id': 'ZYTOP1406'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nimotuzumab & nab-paclitaxel & cisplatin', 'description': 'Nimotuzumab: 200mg,IV once a week during chemotherapy.\n\nNab-paclitaxel: 125mg/m2,(IV over 30 min) (days 1 and 8) on 21 day cycle\n\nCisplatin: 75mg/m2,IV on 21 day cycle', 'interventionNames': ['Drug: Nimotuzumab']}], 'interventions': [{'name': 'Nimotuzumab', 'type': 'DRUG', 'otherNames': ['Anti epidermal growth factor receptor antibody h-R3'], 'description': 'Nimotuzumab: 200mg,IV once a week during chemotherapy.', 'armGroupLabels': ['Nimotuzumab & nab-paclitaxel & cisplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The first affiliated hospital, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Qiong Zhao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital, Zhejiang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Department of Thoracic Oncology', 'investigatorFullName': 'Qiong Zhao', 'investigatorAffiliation': 'Zhejiang University'}}}}