Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT05310305
Status:
UNKNOWN
Last Update Posted:
2022-04-11
First Post:
2022-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PD-1 Antibody and Radiotherapy for Recurrent 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': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-03-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-01', 'studyFirstSubmitDate': '2022-03-26', 'studyFirstSubmitQcDate': '2022-03-26', 'lastUpdatePostDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective remission rate', 'timeFrame': 'One year', 'description': 'Objective remission rate in one month after the end of radiotherapy'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'One year', 'description': 'Progression-free survival after the end of radiotherapy'}, {'measure': 'Overall survival', 'timeFrame': 'One year', 'description': 'Overall survival after the end of radiotherapy'}, {'measure': 'Severe adverse events', 'timeFrame': 'Two years', 'description': 'Severe adverse events during the radiotherapy and the follow-up stage'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Immune Checkpoint Inhibitors', 'Anti-programmed Death-1 Antibody', 'Radiotherapy', 'Recurrent Cervical Carcinoma', 'Metastatic Cervical Carcinoma', 'Persistent Advanced Cervical Carcinoma', 'Objective Remission Rate', 'Progression-free Survival', 'Overall Survival', 'Severe Adverse Events']}, 'descriptionModule': {'briefSummary': 'This study is to investigate retrospectively the effects of combination of immune checkpoint inhibitors anti-programmed death-1 antibody (PD-1 antibody) and radiotherapy for recurrent, metastatic and persistent advanced cervical carcinomas. Patients may or may not accept PD-1 antibody as maintenance therapy. Patients are followed up and the survival outcomes are evaluated. The primary endpoint are objective remission rate. The secondary endpoints are progression-free survival, overall survival and severe adverse events.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with recurrent, metastatic and persistent advanced cervical carcinomas', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years or older\n* Confirmed of recurrent, metastatic, and persistent advanced cervical cancer\n* Confirmed of subtypes of cervical squamous carcinoma, adenocarcinoma and adenosquamous carcinoma\n* Accepting radiotherapy with concurrent anti PD-1 therapy\n* With detailed follow-up outcomes\n\nExclusion Criteria:\n\n\\- Not meeting all of the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT05310305', 'briefTitle': 'PD-1 Antibody and Radiotherapy for Recurrent Cervical Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Combination of Immune Checkpoint Inhibitors PD-1 Monoclonal Antibody and Radiotherapy for Recurrent, Metastatic and Persistent Advanced Cervical Cancer: A Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'IMURADIO1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Radiotherapy for targeted lesions and PD-1 antibody', 'type': 'COMBINATION_PRODUCT', 'description': 'Radiotherapy for targeted lesions in all enrolled participants, with concurrent PD-1 antibody. Patients may or may not accept subsequent PD-1 as maintenance therapy.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lei Li, MD', 'role': 'CONTACT', 'email': 'lileigh@163.com', 'phone': '008613911988831'}], 'facility': 'Lei Li', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Lei Li, M.D.', 'role': 'CONTACT', 'email': 'lileigh@163.com', 'phone': '86-139-1198-8831'}], 'overallOfficials': [{'name': 'Lei Li, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lei Li', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Lei Li', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}