Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-01-29 @ 1:29 PM
Study NCT ID:
NCT03906058
Status:
COMPLETED
Last Update Posted:
2023-10-25
First Post:
2019-04-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anlotinib in Recurrent or Metastatic Nasopharyngeal Carcinoma Patients After Failure of no Less Than Second-line Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077274', 'term': 'Nasopharyngeal Carcinoma'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000625192', 'term': 'anlotinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-22', 'studyFirstSubmitDate': '2019-04-05', 'studyFirstSubmitQcDate': '2019-04-05', 'lastUpdatePostDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'disease control rate', 'timeFrame': '30 months', 'description': 'disease control rate'}], 'secondaryOutcomes': [{'measure': 'overall response rate', 'timeFrame': '30 months', 'description': 'overall response rate'}, {'measure': 'progression-free survival', 'timeFrame': '30 months', 'description': 'progression-free survival'}, {'measure': 'overall survival', 'timeFrame': '30 months', 'description': 'overall survival'}, {'measure': 'duration of response', 'timeFrame': '30 months', 'description': 'duration of response'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nasopharyngeal Carcinoma']}, 'referencesModule': {'references': [{'pmid': '37936166', 'type': 'DERIVED', 'citation': 'Fang Y, Su N, Zou Q, Cao Y, Xia Y, Tang L, Tian X, Liu P, Cai Q. Anlotinib as a third-line or further treatment for recurrent or metastatic nasopharyngeal carcinoma: a single-arm, phase 2 clinical trial. BMC Med. 2023 Nov 7;21(1):423. doi: 10.1186/s12916-023-03140-x.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this single arm, phase Ⅱ clinical trial is to evaluate the efficacy and safety of Anlotinib Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma after failure of no less than second-line chemotherapy or targeted therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* biopsy proved nasopharyngeal carcinoma;\n* stage IVB according to American Joint Committee on Cancer(AJCC) edition VIII, or recurrent disease after chemotherapy and/or radiotherapy;\n* 18 years or older; without other malignancy;\n* proper functioning of the major organs.\n\nExclusion Criteria:\n\n* allergic to anlotinib;\n* female within gestation period or lactation;\n* patients received drug of other clinical trial within 4 weeks.'}, 'identificationModule': {'nctId': 'NCT03906058', 'briefTitle': 'Anlotinib in Recurrent or Metastatic Nasopharyngeal Carcinoma Patients After Failure of no Less Than Second-line Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Open-Label, Phase Ⅱ Study of Anlotinib Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma After Failure of no Less Than Second-line Chemotherapy or Targeted Therapy', 'orgStudyIdInfo': {'id': 'B2018-167'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anlotinib', 'interventionNames': ['Drug: Anlotinib']}], 'interventions': [{'name': 'Anlotinib', 'type': 'DRUG', 'description': 'All patients enrolled in the study will accept anlotinib treatment as a palliative treatment .', 'armGroupLabels': ['Anlotinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician', 'investigatorFullName': 'Qingqing Cai', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}