Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-25 @ 6:30 AM
Study NCT ID:
NCT03945604
Status:
COMPLETED
Last Update Posted:
2022-08-12
First Post:
2019-05-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Apatinib and Fluzoparib in Patients With TNBC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}], 'ancestors': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000631724', 'term': 'camrelizumab'}, {'id': 'C553458', 'term': 'apatinib'}, {'id': 'C000722917', 'term': 'fluzoparib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-09', 'studyFirstSubmitDate': '2019-05-09', 'studyFirstSubmitQcDate': '2019-05-09', 'lastUpdatePostDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose Limiting Toxicity (DLT)', 'timeFrame': 'First cycle (28 days)', 'description': 'Dose Limiting Toxicity'}], 'secondaryOutcomes': [{'measure': 'Adverse Events and Serious Adverse Events', 'timeFrame': 'from the first drug administration to within 90 days for the last SHR-1210 dose', 'description': 'AEs and SAEs'}, {'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'up to 12 months (approx) from the start of treatment'}, {'measure': 'Duration of response (DoR)', 'timeFrame': 'up to 12 months (approx) from the start of treatment'}, {'measure': 'Disease Control Rate', 'timeFrame': 'up to 12 months (approx) from the start of treatment', 'description': 'DCR'}, {'measure': 'Progression-Free-Survival', 'timeFrame': 'up to 12 months (approx) from the start of treatment', 'description': 'PFS'}, {'measure': '12-months overall survival rate', 'timeFrame': 'From the start of treatment to 1 year', 'description': '12-months overall survival rate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Triple Negative Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '36184642', 'type': 'DERIVED', 'citation': 'Zhang Q, Shao B, Tong Z, Ouyang Q, Wang Y, Xu G, Li S, Li H. A phase Ib study of camrelizumab in combination with apatinib and fuzuloparib in patients with recurrent or metastatic triple-negative breast cancer. BMC Med. 2022 Oct 3;20(1):321. doi: 10.1186/s12916-022-02527-6.'}]}, 'descriptionModule': {'briefSummary': 'The study is being conducted to evaluate the tolerability, safety and efficacy of SHR-1210 in combination with Apatinib and Fluzoparib in subjects with recurrent and metastatic triple negative breast cancer', 'detailedDescription': 'Drug: SHR-1210 + Apatinib +Fluzoparib SHR-1210 will be administered as an intravenous infusion, Apatinib tablets will be given orally, Fluzoparib capsule will be given orally 28 days per cycle, until disease progression or unacceptable toxicity.\n\nTreatment group ： PD-1 antibody SHR-1210 combination with apatinib and fluzoparib'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'only female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed the informed consent.\n* Female aged ≥18 years old.\n* Histologically diagnosed patients with recurrent and metastatic triple negative breast cancer.\n* No more than 2-line chemotherapy failed at the stage of recurrence and metastasis .\n* Patients who have been treated with platinum-based regimen at the stage of recurrence/metastasis need non-disease progression (non-pd)during treatment\n* At least one measuring lesion that confirmed by RECIST v1.1 standard.\n* The patients can swallow pills.\n* Have a life expectancy of at least 12 weeks.\n* The functions of vital organs meet protocal requirements.\n\nExclusion Criteria:\n\n* Subjects had any history of active autoimmune disease .\n* Subjects had previously been treated with anti-PD-1 and PD-L1 antibodies, or was known to be allergic to antibody drugs, or had previously been treated with apatinib, or had previously been treated with PARP inhibitors.\n* Subjects have untreated central nervous system metastasis.\n* History of hypertension and antihypertensive medications are not well controlled.\n* Some clinical symptoms or diseases of the heart that are not well controlled.\n* History of immunodeficiency including HIV-positive.\n* Subjects had active infections.'}, 'identificationModule': {'nctId': 'NCT03945604', 'briefTitle': 'A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Apatinib and Fluzoparib in Patients With TNBC', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'A Phase Ib，Open-labeled, Multi-center, Dose-exploring Trial of SHR-1210 (Anti-PD-1 Antibody) in Combination With Apatinib and Fluzoparib in Subjects With Recurrent and Metastatic Triple Negative Breast Cancer', 'orgStudyIdInfo': {'id': 'FZPL-Ib-105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR-1210 + Apatinib +Fluzoparib', 'description': 'SHR-1210 will be administered as an intravenous infusion Apatinib tablets will be given orally Fluzoparib capsule will be given orally 28 days per cycle, until disease progression or unacceptable toxicity', 'interventionNames': ['Drug: SHR-1210 + Apatinib +Fluzoparib']}], 'interventions': [{'name': 'SHR-1210 + Apatinib +Fluzoparib', 'type': 'DRUG', 'otherNames': ['Treatment group ： PD-1 antibody SHR-1210 combination with apatinib and fluzoparib'], 'description': 'SHR-1210 will be administered as an intravenous infusion Apatinib tablets will be given orally Fluzoparib capsule will be given orally 28 days per cycle, until disease progression or unacceptable toxicity.', 'armGroupLabels': ['SHR-1210 + Apatinib +Fluzoparib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Cancer Hosptial', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Huiping Li, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Cancer Hosptial'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}