Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT05095558
Status:
UNKNOWN
Last Update Posted:
2021-10-27
First Post:
2021-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Microtransplantation for Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-26', 'studyFirstSubmitDate': '2021-10-26', 'studyFirstSubmitQcDate': '2021-10-26', 'lastUpdatePostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment-Emergent Adverse Events', 'timeFrame': '1 month', 'description': 'Treatment related mortality'}, {'measure': 'time of hematopoietic recovery', 'timeFrame': '1 month', 'description': 'Absolute neutrophil count \\>500/mcL; Platelets ≥20,000/mcL'}], 'secondaryOutcomes': [{'measure': 'overall response rate', 'timeFrame': '1year', 'description': '(markedly effective + effective) / number of patients × 100%'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['microtransplantation'], 'conditions': ['Ovarian Cancer Recurrent']}, 'descriptionModule': {'briefSummary': 'In this study, we will apply micro transplantation to the field of recurrent and advanced ovarian cancer to study the efficacy and safety.', 'detailedDescription': "The eligible patients are assigned to the experimental group (microtransplantation group, MST group) or the control group (CT) according to the availability of suitable donors. In MST group, peripheral blood hematopoietic stem cells from HLA mismatched donors mobilized with granulocyte colony stimulating factor are infused after conventional chemotherapy and/or radiotherapy ; The CT group only received conventional chemotherapy and/or radiotherapy. According to the patient's past medical history, current tumor assessment results, and the latest cancer treatment guidelines, the individualized chemotherapy and / or radiotherapy plan for the patient is formulated after discussion by more than 3 oncologists. After each course of treatment, the efficacy and safety are evaluated. For the patients who are evaluated to be effective or stable (SD) after the first treatment, the second treatment of the same scheme will be given. Those who reach the disease control level will continue to be treated for 4 courses, with an interval of 28 days. The patients who failed to achieve the improvement of SD after two cycles of chemotherapy will be withdrawn from the study. Patients are allowed to receive any treatment, including symptomatic support treatment, after the end of treatment or withdrawal from the study."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients are 18-80 years old, female，regardless of race;\n* Advanced / relapsed ovarian cancer confirmed by clinical or histopathological diagnosis;\n* More than two kinds of tumors are allowed;\n* Karnofsky score ≥ 60, ECoG physical status ≤ 2;\n* Sensitive to chemotherapy or radiotherapy;\n* There are measurable lesions;\n* There are suitable hematopoietic stem cell donors\n\nExclusion Criteria:\n\n* have no suitable donor or donor refused\n* patient refused to accept donor cells'}, 'identificationModule': {'nctId': 'NCT05095558', 'briefTitle': 'Microtransplantation for Ovarian Cancer', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Hospital of the Chinese Academy of Military Medical Sciences'}, 'officialTitle': 'Microtransplantation for Ovarian Cancer', 'orgStudyIdInfo': {'id': 'MST-OC-2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MST', 'description': 'standard chemotherapy with microtransplantation', 'interventionNames': ['Biological: microtransplantation, HLA-mismatched donor peripheral stem cell infusion']}, {'type': 'NO_INTERVENTION', 'label': 'CT', 'description': 'standard chemotherapy only, without microtransplantation'}], 'interventions': [{'name': 'microtransplantation, HLA-mismatched donor peripheral stem cell infusion', 'type': 'BIOLOGICAL', 'otherNames': ['DSI'], 'description': 'infusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood stem cells (GPBSC)', 'armGroupLabels': ['MST']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weiping Li', 'role': 'CONTACT', 'email': '15811031508@163.com', 'phone': '+8615811031508'}], 'facility': 'The third medical center of PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'WEIPING LI', 'role': 'CONTACT', 'email': '15811031508@163.com', 'phone': '+8615811031508'}, {'name': 'QIYUN Sun', 'role': 'CONTACT', 'email': '13651058454@139.com', 'phone': '+8613651058454'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Hospital of the Chinese Academy of Military Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}