Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-29 @ 6:55 AM
Study NCT ID:
NCT07167160
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chemo-immunotherapy for Cervical Cancer Stage IIICp Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 59}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-09-01', 'studyFirstSubmitQcDate': '2025-09-09', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3-year disease-free survival rate', 'timeFrame': 'from enrollment until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 100 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Cancer', 'Immunochemotherapy']}, 'descriptionModule': {'briefSummary': 'Efficacy evaluation of camrelizumab combined with chemotherapy for adjuvant treatment of patients with pathologically confirmed lymph node-positive cervical cancer after staging surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with cervical cancer staged FIGO2018 IIIC1p or IIIC2p after radical surgery;\n2. Positive PD-L1 expression;\n3. ECOG score ≤1\n\nExclusion Criteria:\n\n1. Positive parametrium or surgical margin;\n2. Incomplete radical surgery;\n3. Residual target lesions;\n4. Active autoimmune disease or autoimmune disease requiring systemic treatment;\n5. Previous treatment with immune checkpoint inhibitors.'}, 'identificationModule': {'nctId': 'NCT07167160', 'briefTitle': 'Chemo-immunotherapy for Cervical Cancer Stage IIICp Trial', 'organization': {'class': 'OTHER', 'fullName': "Women's Hospital School Of Medicine Zhejiang University"}, 'officialTitle': 'Camrelizumab Combined With Chemotherapy for Adjuvant Treatment of Cervical Cancer Patients With Pathologically Confirmed Lymph Node Positivity After Stage Surgery: A Prospective, Single-Arm, Multicenter, Phase II Clinical Trial', 'orgStudyIdInfo': {'id': 'IRB-20250023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'chemotherapy group', 'interventionNames': ['Drug: Camrelizumab combined with chemotherapy']}], 'interventions': [{'name': 'Camrelizumab combined with chemotherapy', 'type': 'DRUG', 'description': 'Camrelizumab combined with chemotherapy for adjuvant treatment of patients with pathologically confirmed lymph node-positive cervical cancer after staging surgery', 'armGroupLabels': ['chemotherapy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tingting Chen', 'role': 'CONTACT', 'email': '11318160@zju.edu.cn', 'phone': '86-13738102530'}], 'facility': "Women's Hospital, School of Medicine, Zhejiang University", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Women's Hospital School Of Medicine Zhejiang University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}