Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2026-02-24 @ 8:47 AM
Study NCT ID:
NCT02487693
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2016-02-23
First Post:
2015-06-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Ovarian Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal 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': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}], 'ancestors': [{'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2040-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-02-21', 'studyFirstSubmitDate': '2015-06-29', 'studyFirstSubmitQcDate': '2015-06-30', 'lastUpdatePostDateStruct': {'date': '2016-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2038-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence-free survival', 'timeFrame': '1 year', 'description': 'Recurrence-free survival (RFS) was defined as the time from the date of RFA to the date of recurrence or the date of the last follow-up.'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': '4 weeks', 'description': 'Adverse events related to RFA and CIK treatments.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Ovarian Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether combining of radiofrequency ablation (RFA) and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with ovarian carcinoma.', 'detailedDescription': 'The primary objective is to evaluate whether RFA followed by CIK transfusion can prolong survival of patients with ovarian carcinoma.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patients diagnosed with FIGO stage II ovarian carcinoma;\n2. cytoreductive surgery performed and 6 courses of platinum-based chemotherapy completed;\n3. medical records maintain comprehensive data on treatment and follow-up;\n4. no history of previous malignancies.\n\nExclusion Criteria:\n\n1. neoadjuvant chemotherapy applied;\n2. less than 6 courses of chemotherapy or more than 6 courses of chemotherapy completed;\n3. medical records maintain incomplete data on treatment or follow-up;\n4. history of previous malignancy.'}, 'identificationModule': {'nctId': 'NCT02487693', 'briefTitle': 'Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Ovarian Carcinoma', 'organization': {'class': 'OTHER', 'fullName': "The First People's Hospital of Changzhou"}, 'orgStudyIdInfo': {'id': 'ovarian001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'RFA alone', 'description': 'Patients undergo radiofrequency ablation alone.'}, {'type': 'EXPERIMENTAL', 'label': 'RFA+CIK', 'description': 'Autologous cytokine-induced killer cells were transfer via venous one week after RFA Interventions', 'interventionNames': ['Procedure: Radiofrequency ablation', 'Biological: Cytokine-induced killer cells']}], 'interventions': [{'name': 'Radiofrequency ablation', 'type': 'PROCEDURE', 'otherNames': ['RFA'], 'description': 'Radiofrequency ablation is performed percutaneously under CT/US guidance', 'armGroupLabels': ['RFA+CIK']}, {'name': 'Cytokine-induced killer cells', 'type': 'BIOLOGICAL', 'otherNames': ['CIK'], 'description': 'The patients received autologous cytokine-induced killer cells transfusion one week after RFA treatment.', 'armGroupLabels': ['RFA+CIK']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "The First People's Hospital of Changzhou", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}