Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2026-01-01 @ 11:45 PM
Study NCT ID:
NCT04713059
Status:
UNKNOWN
Last Update Posted:
2021-07-01
First Post:
2021-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Toripalimab Combined With Anlotinib for Patients With Advanced, Relapsed, or Refractory Gastric, or Esophagogastric Junction Cancer (EGJC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 62}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-29', 'studyFirstSubmitDate': '2021-01-14', 'studyFirstSubmitQcDate': '2021-01-14', 'lastUpdatePostDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ORR', 'timeFrame': '01.01.2019 to 01.01.2021'}, {'measure': '6m-PFS', 'timeFrame': '01.01.2019 to 01.01.2021'}, {'measure': 'safety', 'timeFrame': '01.01.2019 to 01.01.2021'}], 'secondaryOutcomes': [{'measure': 'PFS', 'timeFrame': '01.01.2019 to 01.01.2021'}, {'measure': 'OS', 'timeFrame': '01.01.2019 to 01.01.2021'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric or Gastro-oesophageal Junction Carcinoma', 'Advanced, Relapsed Gastric or Gastro-oesophageal Junction Carcinoma', 'Second-line Therapy']}, 'referencesModule': {'references': [{'pmid': '35857405', 'type': 'DERIVED', 'citation': 'Jiang M, Zhang C, Hu Y, Li T, Yang G, Wang G, Zhu J, Shao C, Hou H, Zhou N, Liu K, Zhang X. Anlotinib Combined with Toripalimab as Second-Line Therapy for Advanced, Relapsed Gastric or Gastroesophageal Junction Carcinoma. Oncologist. 2022 Nov 3;27(11):e856-e869. doi: 10.1093/oncolo/oyac136.'}]}, 'descriptionModule': {'briefSummary': 'Patients were aged \\>18 years with histological confirmed GC/EGJC and were refractory to the first line of therapy. Additional eligibility requirements included: ≥1 measurable disease at baseline per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v 1.1); Eastern Cooperative Oncology Group Performance status of 0 or 1; or life expectancy of ≥ 3 months and adequate organ function. The main exclusion criteria were interstitial lung disease, pulmonary fibrosis, active or prior autoimmune disease or active hepatitis, or history of anlotinib or any other PD-L1/PD-1 antagonist treatment. Patients with abdominal fistula, diverticulitis, gastrointestinal ulcerative disease or perforation, or abdominal abscess within the prior 4 weeks were also excluded. This study was an open, exploratory single-arm, phase II trial. Enrolled patients received anlotinib (12mg, po. qd, d1-14) combined with toripalimab (240 mg, inv, over 30 min once every 2 weeks).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients were aged \\>18 years with histological confirmed GC/EGJC and were refractory to the first line of therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients were aged \\>18 years with histological confirmed GC/EGJC and were refractory to the first line of therapy. Additional eligibility requirements included: ≥1 measurable disease at baseline per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v 1.1); Eastern Cooperative Oncology Group Performance status of 0 or 1; or life expectancy of ≥ 3 months and adequate organ function.\n\nExclusion Criteria:\n\nThe main exclusion criteria were interstitial lung disease, pulmonary fibrosis, active or prior autoimmune disease or active hepatitis, or history of anlotinib or any other PD-L1/PD-1 antagonist treatment. Patients with abdominal fistula, diverticulitis, gastrointestinal ulcerative disease or perforation, or abdominal abscess within the prior 4 weeks were also excluded.'}, 'identificationModule': {'nctId': 'NCT04713059', 'briefTitle': 'Toripalimab Combined With Anlotinib for Patients With Advanced, Relapsed, or Refractory Gastric, or Esophagogastric Junction Cancer (EGJC)', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Hospital of Qingdao University'}, 'officialTitle': 'The Affiliated Hospital of Qingdao University', 'orgStudyIdInfo': {'id': 'CAANGC/EJGC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with CPS ≥ 1 or MSI-H or TMB ≥ 10Mb/MUT', 'interventionNames': ['Genetic: FGFR2']}, {'label': 'patients with CPS =0 , MSS and TMB < 10Mb/mut', 'interventionNames': ['Genetic: FGFR2']}], 'interventions': [{'name': 'FGFR2', 'type': 'GENETIC', 'description': 'Mutation of FGFR2', 'armGroupLabels': ['patients with CPS =0 , MSS and TMB < 10Mb/mut', 'patients with CPS ≥ 1 or MSI-H or TMB ≥ 10Mb/MUT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '266003', 'city': 'Qingdao', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Man Jiang', 'role': 'CONTACT', 'email': 'jasmanouc@163.com', 'phone': '+8653282913271'}], 'facility': 'Xiaochun Zhang', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}], 'centralContacts': [{'name': 'Man Jiang', 'role': 'CONTACT', 'email': 'jasmanouc@163.com', 'phone': '+8653282913271'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Hospital of Qingdao University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'The Affiliated Hospital of Qingdao University', 'investigatorFullName': 'zhangxiaochun', 'investigatorAffiliation': 'The Affiliated Hospital of Qingdao University'}}}}