Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2026-03-09 @ 9:20 PM
Study NCT ID:
NCT02011594
Status:
WITHDRAWN
Last Update Posted:
2015-02-12
First Post:
2013-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Study of Maintenance Treatment of Nimotuzumab for Advanced Esophageal Carcinoma
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': 'C501466', 'term': 'nimotuzumab'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'There was no participants enrolled in this clinical trial.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-11', 'studyFirstSubmitDate': '2013-12-07', 'studyFirstSubmitQcDate': '2013-12-09', 'lastUpdatePostDateStruct': {'date': '2015-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS (Progression free survival)', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate', 'timeFrame': '6 months'}, {'measure': 'Overall survival (OS)', 'timeFrame': '12 months'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'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. However, whether maintenance therapy of nimotuzumab provides benefit to advanced esophageal cancer patients is not known.', 'detailedDescription': 'We design this clinical trial to confirm the efficacy of maintenance treatment of nimotuzumab after initial treatment.'}, '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* The sample size estimate: 20 cases per arm.\n* Males or females aged ≥18 years, \\< 75 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Life expectancy ≥12 weeks.\n* Males and females should be contraceptive during the period of the trial until 8 weeks after the last administration of the drug.\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* Institutional review board-approved informed consent will be obtained for every patient before initiation of any trial-specific procedure or treatment.\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': 'NCT02011594', 'briefTitle': 'Phase II Study of Maintenance Treatment of Nimotuzumab for Advanced Esophageal Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Phase II Study of Maintenance Treatment of Nimotuzumab Versus No Maintenance for Advanced Esophageal Carcinoma', 'orgStudyIdInfo': {'id': 'ZYTOP1407'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'Nimotuzumab', 'interventionNames': ['Drug: Nimotuzumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm B', 'description': 'Placebo (normal saline)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Nimotuzumab', 'type': 'DRUG', 'otherNames': ['Anti epidermal growth factor receptor antibody h-R3'], 'description': '400mg Q2W intravenously', 'armGroupLabels': ['Arm A']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Normal saline'], 'description': 'Normal saline', 'armGroupLabels': ['Arm B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Qiong Zhao', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'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, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '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'}}}}