Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2026-01-05 @ 5:52 PM
Study NCT ID:
NCT01180166
Status:
UNKNOWN
Last Update Posted:
2013-09-19
First Post:
2010-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of Nimotuzumab,Capecitabine and Radiotherapy for Inoperable or Recurrent Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach 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': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-09-17', 'studyFirstSubmitDate': '2010-08-03', 'studyFirstSubmitQcDate': '2010-08-11', 'lastUpdatePostDateStruct': {'date': '2013-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression-free survival', 'timeFrame': '1 year progression-free survival', 'description': 'progression-free survival: the time between tumor regression to progression'}], 'secondaryOutcomes': [{'measure': 'overall responses', 'timeFrame': '1 month after treatment', 'description': 'the overall responses: complete response (CR)+ partial response(PR)+ stable disease (SD) rates based on World Health Organization(WHO) evaluation system'}, {'measure': 'overall survival time', 'timeFrame': '1 month after treatment', 'description': 'median overall survival time'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Gastric cancer', 'concurrent chemoradiotherapy', 'target therapy'], 'conditions': ['Gastric Cancer', 'Concurrent Chemoradiotherapy']}, 'descriptionModule': {'briefSummary': 'The prognosis of patients with inoperable locally advanced or residual/relapsed gastric cancer is rather poor. Concurrent capecitabine chemoradiotherapy is safe and recommended. Nimotuzumab, an anti-EGFR (epidermal growth factor receptor) monoclonal antibody, has shown its antitumor safety and efficiency in many phase I/II studies. Efficiency of combination of these treatment need to be further analyzed.', 'detailedDescription': 'There is no standard treatment for patients with inoperable locally advanced or residual/relapsed gastric cancer. For the former ones, 5-fluorouracil(5-FU) based concurrent chemoradiotherapy is a recommended treatment regimen. Concurrent capecitabine chemoradiotherapy showed similar results. So far, more and more studies have shown that drugs targeting at EGFRs play an important role in antitumor treatment. Nimotuzumab, an anti-EGFR monoclonal antibody, has shown its safety and efficiency in many phase I/II studies. Because of poor survival of patients with inoperable locally advanced or residual/relapsed gastric cancer, the efficiency of nimotuzumab plus concurrent capecitabine chemoradiotherapy need to be further analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-75 years old, male or female\n* Gastric cancer with measurable lesions, and the diameter is at least 1 cm\n* Karnofsky score: at least 70\n* Estimated survival: at least 6 months\n* No prior target therapy or radiotherapy\n* No severe hypertension, cardiac disease, or diabetes mellitus\n* Normal blood routine and chemical tests\n* Signed consent\n\nExclusion Criteria:\n\n* Other malignancies simultaneously except in situ cervix or non-melanoma skin cancer\n* Extensive distant metastases\n* Pregnancy or in lactation\n* Allergic to 5-Fluorouracil'}, 'identificationModule': {'nctId': 'NCT01180166', 'briefTitle': 'Combination of Nimotuzumab,Capecitabine and Radiotherapy for Inoperable or Recurrent Gastric Cancer', 'organization': {'class': 'UNKNOWN', 'fullName': 'ChineseAMS'}, 'officialTitle': 'Phase II Study of Nimotuzumab and Concurrent Radiotherapy and Capecitabine for Inoperable Locally Advanced or Recurrent Gastric Cancer', 'orgStudyIdInfo': {'id': 'CH-GI-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'nimotuzumab', 'description': 'Combination of nimotuzumab and capecitabine concurrent chemoradiotherapy is received by patients.', 'interventionNames': ['Drug: nimotuzumab']}], 'interventions': [{'name': 'nimotuzumab', 'type': 'DRUG', 'otherNames': ['Nimotuzumab injection, Tai Xin-sheng'], 'description': '200 milligram (mg) of nimotuzumab per week during radiation period', 'armGroupLabels': ['nimotuzumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ningning Lu, Doctor', 'role': 'CONTACT', 'email': 'ykyzlyy@hotmail.com', 'phone': '+86 01087788280'}, {'name': 'Jing Jin, M.D.', 'role': 'CONTACT', 'email': 'jingjin1025@163.com', 'phone': '+86 01087788280'}, {'name': 'Jing Jin, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Ningning Lu, Doctor', 'role': 'CONTACT', 'email': 'ykyzlyy@hotmail.com', 'phone': '+86 01087788280'}, {'name': 'Jing Jin, M.D.', 'role': 'CONTACT', 'email': 'jingjin1025@163.com', 'phone': '+86 0108778280'}], 'overallOfficials': [{'name': 'jing jin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese Acedemy of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'vice chair of radiation department, Chinese Academy of Medical Sciences', 'investigatorFullName': 'Jing Jin, M.D.', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences'}}}}