Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT03732508
Status:
UNKNOWN
Last Update Posted:
2018-11-06
First Post:
2018-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SHR-1316 in Combination With Chemotherapy in Patients With Esophageal Squamous Cell Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C584112', 'term': 'irinotecan sucrosofate'}, {'id': 'D005472', 'term': 'Fluorouracil'}], 'ancestors': [{'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, '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': '2018-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-05', 'studyFirstSubmitDate': '2018-10-31', 'studyFirstSubmitQcDate': '2018-11-05', 'lastUpdatePostDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of Progression-Free Survival (PFS)', 'timeFrame': 'approximately 22 months', 'description': 'based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)'}], 'secondaryOutcomes': [{'measure': 'Disease Control Rate(DCR)', 'timeFrame': 'approximately 22 months', 'description': 'based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)'}, {'measure': 'Objective Response Rate(ORR)', 'timeFrame': 'approximately 22 months', 'description': 'based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)'}, {'measure': 'Overall Survival(OS)', 'timeFrame': 'approximately 22 months', 'description': 'OS is defined as the time from registration to death due to any cause, or censored at date last known alive.'}, {'measure': 'Adverse Events(AE)', 'timeFrame': 'approximately 22 months', 'description': 'adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Esophageal Squamous Cell Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the progression-free survival (PFS) of Chemotherapy combined with SHR-1316 in patients with advanced esophageal squamous cell cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically or cytologically confirmed unresectable local advanced/recurrent or metastasis esophageal squamous cell carcinoma;\n2. No previous systemic anti-tumor treatment;\n3. Subjects must have at least one measurable tumor lesion per RECIST 1.1;\n4. ECOG: 0-1;\n5. Adequate organ and bone marrow function;\n\nExclusion Criteria:\n\n1. Allergic to monoclonal antibodies, any SHR-1316 components,Irinotecan , Fluorouracil ;\n2. Prior therapy as follow:\n\n 1. Anti-PD-1 or anti-PD-L1;\n 2. Any experimental drugs within 4 weeks of the first dose of study medication;\n 3. Received major operations or serious injuries within 4 weeks of the first dose of study medication;\n 4. Received last dose of anticancer therapy (including chemotherapy, radiotherapy, targeted therapy, etc.) within 4 weeks of the first dose of study medication;\n3. Not recovered to ≤CTCAE 1 from adverse events (except for hair loss) due to a previously anti-tumor treatment;\n4. Subjects with any active autoimmune disease or history of autoimmune disease;\n5. Pregnancy or breast feeding;'}, 'identificationModule': {'nctId': 'NCT03732508', 'briefTitle': 'SHR-1316 in Combination With Chemotherapy in Patients With Esophageal Squamous Cell Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'SHR-1316, a Novel Anti-PD-L1 Antibody, in Combination With Irinotecan Liposome and Fluorouracil in Patients With Esophageal Squamous Cell Cancer: a Phase II Study', 'orgStudyIdInfo': {'id': 'IRI-SHR-1316-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Irinotecan liposome plus SHR1316 plus fluorouracil', 'interventionNames': ['Drug: Irinotecan liposome', 'Drug: SHR-1316', 'Drug: Fluorouracil']}], 'interventions': [{'name': 'Irinotecan liposome', 'type': 'DRUG', 'description': 'Irinotecan liposome intravenous infusion will be administered during the first day of treatment.', 'armGroupLabels': ['Irinotecan liposome plus SHR1316 plus fluorouracil']}, {'name': 'SHR-1316', 'type': 'DRUG', 'description': 'SHR-1316 intravenous infusion will be administered during the first day of treatment.', 'armGroupLabels': ['Irinotecan liposome plus SHR1316 plus fluorouracil']}, {'name': 'Fluorouracil', 'type': 'DRUG', 'description': 'Fluorouracil intravenous infusion will be administered during the first day of treatment.', 'armGroupLabels': ['Irinotecan liposome plus SHR1316 plus fluorouracil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jing Huang', 'role': 'CONTACT'}], 'facility': 'Cancer Institute and Hospital,Chinese Academy of Medical Science', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Fei Shi', 'role': 'CONTACT', 'email': 'hrshifei@163.com', 'phone': '+86-18036618733'}], 'overallOfficials': [{'name': 'Jing Huang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}