Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2026-01-01 @ 11:49 PM
Study NCT ID:
NCT04906993
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-09
First Post:
2021-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Camrelizumab Combined With Famitinib Malate for Treatment of Recurrent/Metastatic Cervical Cancer
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': 'D017671', 'term': 'Platinum Compounds'}], 'ancestors': [{'id': 'D007287', 'term': 'Inorganic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1:1 camrelizumab combined with famitinib malate platinum-based chemotherapy'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 443}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2021-05-26', 'studyFirstSubmitQcDate': '2021-05-26', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival (PFS) assessed by the BIRC based on RECIST V1.1 criteria', 'timeFrame': 'up to 2 years'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'up to 3 years'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival (PFS) assessed by the investigator based on RECIST V1.1 criteria', 'timeFrame': 'up to 2 years'}, {'measure': 'Objective response rate (ORR) assessed based on RECIST V1.1 criteria', 'timeFrame': 'up to 2 years'}, {'measure': 'Disease control rate (DCR) assessed based on RECIST V1.1 criteria', 'timeFrame': 'up to 2 years'}, {'measure': 'Duration of response (DOR) assessed based on RECIST V1.1 criteria', 'timeFrame': 'up to 2 years'}, {'measure': 'Time to response (TTR) assessed based on RECIST V1.1 criteria', 'timeFrame': 'up to 2 years'}, {'measure': 'Time to treatment failure (TTF)', 'timeFrame': 'up to 2 years'}, {'measure': 'Progression-free survival (PFS) in subjects in the control group who receive camrelizumab after progression', 'timeFrame': 'up to 2 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Cancer']}, 'descriptionModule': {'briefSummary': 'This study is a randomized, open-label, controlled, multi-center Phase III clinical study, aimed to evaluate the efficacy and safety of camrelizumab combined with famitinib malate versus platinum-based chemotherapy in the treatment of recurrent/metastatic cervical cancer. All enrolled patients will be randomly divided into 2 groups and continuously treated until any event that meets the criteria for end of the clinical trial.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female aged 18-75 years (including 18 and 75 years, calculated based on the signing date of the informed consent)\n2. Histopathologically confirmed recurrent/metastatic cervical squamous cell carcinoma that cannot be radically treated by surgery, radiotherapy or chemoradiotherapy\n3. No prior systemic anti-cancer therapy for recurrent/metastatic disease\n4. According to RECIST v1.1 criteria, the patient must have at least one measurable lesion\n5. Able to normally swallow drug tablets\n6. The organ function level is good\n7. Willing to participate and able to comply with research programme requirements\n\nExclusion Criteria:\n\n1. Has any malignancy \\<5 years prior to study entry.\n2. Known to have brain or meningeal metastasis\n3. Known to have autoimmune disease\n4. Received live vaccinations 4 weeks before randomization or during the study period'}, 'identificationModule': {'nctId': 'NCT04906993', 'briefTitle': 'Camrelizumab Combined With Famitinib Malate for Treatment of Recurrent/Metastatic Cervical Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'A Randomized, Open-Label, Controlled, Multi-Center Phase III Clinical Study of Camrelizumab Combined With Famitinib Malate Versus Platinum-based Chemotherapy in the Treatment of Recurrent/Metastatic Cervical Cancer', 'orgStudyIdInfo': {'id': 'SHR-1210-III-329'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'camrelizumab combined with famitinib malate', 'interventionNames': ['Drug: camrelizumab； famitinib malate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'platinum-based chemotherapy', 'interventionNames': ['Drug: platinum-based chemotherapy']}], 'interventions': [{'name': 'camrelizumab； famitinib malate', 'type': 'DRUG', 'description': 'Camrelizumab intravenously ; Famitinib Orally', 'armGroupLabels': ['camrelizumab combined with famitinib malate']}, {'name': 'platinum-based chemotherapy', 'type': 'DRUG', 'description': "Physician's choice chemotherapy", 'armGroupLabels': ['platinum-based chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}