Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-22 @ 8:28 AM
Study NCT ID:
NCT06237257
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-24
First Post:
2024-01-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Chemoradiotherapy With SHR-1316 For Treatment of Locally Advanced Cervical Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-19', 'studyFirstSubmitDate': '2024-01-23', 'studyFirstSubmitQcDate': '2024-01-23', 'lastUpdatePostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Type, incidence and grade of drug-related adverse events of grade 3 and above', 'timeFrame': 'Up to approximately 24 months'}], 'secondaryOutcomes': [{'measure': 'Adverse events (AEs) include incidence, grade (judged according to NCI-CTCAE V5.0 standards), duration and correlation with study drugs', 'timeFrame': 'Up to approximately 30 months'}, {'measure': 'Rate of Suspension and Discontinuation Due to an Adverse Event correlation with study drug', 'timeFrame': 'Up to approximately 30 months'}, {'measure': 'Objective Response Rate(ORR)', 'timeFrame': 'Up to approximately 60 months', 'description': "judged based on RECIST 1.1 criteria according to Investigator's assessment"}, {'measure': 'Duration of response (DoR)', 'timeFrame': 'Up to approximately 60 months', 'description': "judged based on RECIST 1.1 criteria according to Investigator's assessment"}, {'measure': 'Progression free survival (PFS)', 'timeFrame': 'Up to approximately 60 months', 'description': "judged based on RECIST 1.1 criteria according to Investigator's assessment"}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 60 months', 'description': "judged based on RECIST 1.1 criteria according to Investigator's assessment"}, {'measure': '2-year Progression free survival', 'timeFrame': 'Up to approximately 24 months', 'description': "judged based on RECIST 1.1 criteria according to Investigator's assessment"}, {'measure': '3-year Overall Survival', 'timeFrame': 'Up to approximately 36 months', 'description': "judged based on RECIST 1.1 criteria according to Investigator's assessment"}, {'measure': '12-week Complete Response', 'timeFrame': 'Up to approximately 4 months', 'description': "judged based on RECIST 1.1 criteria according to Investigator's assessment"}, {'measure': 'PK traits of SHR-1316: Cmax', 'timeFrame': 'Up to approximately 24 months'}, {'measure': 'PK traits of SHR-1316: Tmax', 'timeFrame': 'Up to approximately 24 months'}, {'measure': 'PK traits of SHR-1316: AUC0-t', 'timeFrame': 'Up to approximately 24 months'}, {'measure': 'PK traits of SHR-1316: AUC0-∞', 'timeFrame': 'Up to approximately 24 months'}, {'measure': 'PK traits of SHR-1316: t1/2', 'timeFrame': 'Up to approximately 24 months'}, {'measure': 'PK traits of SHR-1316: CL', 'timeFrame': 'Up to approximately 24 months'}, {'measure': 'PK traits of SHR-1316: Vss', 'timeFrame': 'Up to approximately 24 months'}, {'measure': 'Serum concentration of SHR-1316 at each planned blood collection time point', 'timeFrame': 'Up to approximately 24 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Locally Advanced Cervical Cancer']}, 'descriptionModule': {'briefSummary': 'The Primary purpose of this study is to evaluate the safety of SHR-1316 plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer.\n\nThe second purpose of this study is to evaluate the efficacy and PK traits; The exploratory study is to explore the biomarker 、immunogenicity and so on .'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Able and willing to provide a written informed consent\n2. Has histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix；\n3. Has locally advanced cervical cancer；\n4. At least one measurable lesion ( RECIST version 1.1)；\n5. Investigator assess it is suitable for concurrent chemoradiotherapy;\n6. Has provided a tissue sample from tumor lesion;\n7. Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n8. BMI≥18.5kg/m2；\n9. Female participants of childbearing potential must agree to use highly effective contraception during the treatment period and for at least 7 months after the last dose of drug，Female participants' HCG must be negative within 3 days prior to enrollment and must be non-lactating.\n\nExclusion Criteria:\n\n1. Histopathologically confirmed small cell carcinoma (neuroendocrine) or mucinous adenocarcinoma of the cervix；\n2. The presence of distant metastatic disease was confirmed by pathology or imaging;\n3. has previously undergone hysterectomy (including subtotal hysterectomy) or plan to undergo hysterectomy for cervical cancer, or plan to adopt fertility preservation therapy;\n4. In the investigator's judgment, there is a disease (such as severe diabetes, neurological or psychiatric illness, etc.) or any other condition that seriously endangers the subject's safety, confuses the study results, or interferes with the subject's ability to complete the study."}, 'identificationModule': {'nctId': 'NCT06237257', 'briefTitle': 'A Study of Chemoradiotherapy With SHR-1316 For Treatment of Locally Advanced Cervical Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Shengdi Pharmaceutical Co., Ltd'}, 'officialTitle': 'A Study of Chemoradiotherapy With SHR-1316 For Treatment of Locally Advanced Cervical Cancer', 'orgStudyIdInfo': {'id': 'SHR-1316-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR-1316 plus concurrent chemoradiotherapy', 'interventionNames': ['Biological: SHR-1316', 'Drug: Cisplatin Injection/Carboplatin Injection', 'Radiation: External Beam Radiotherapy (EBRT)/Brachytherapy', 'Drug: Paclitaxel Injection']}], 'interventions': [{'name': 'SHR-1316', 'type': 'BIOLOGICAL', 'description': 'SHR-1316（Adebrelimab Injection）', 'armGroupLabels': ['SHR-1316 plus concurrent chemoradiotherapy']}, {'name': 'Cisplatin Injection/Carboplatin Injection', 'type': 'DRUG', 'description': 'Cisplatin Injection/Carboplatin Injection', 'armGroupLabels': ['SHR-1316 plus concurrent chemoradiotherapy']}, {'name': 'External Beam Radiotherapy (EBRT)/Brachytherapy', 'type': 'RADIATION', 'description': 'External Beam Radiotherapy (EBRT)/Brachytherapy', 'armGroupLabels': ['SHR-1316 plus concurrent chemoradiotherapy']}, {'name': 'Paclitaxel Injection', 'type': 'DRUG', 'description': 'Paclitaxel Injection.', 'armGroupLabels': ['SHR-1316 plus concurrent chemoradiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Shengdi Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}