Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-31 @ 5:02 AM
Study NCT ID:
NCT01470495
Status:
UNKNOWN
Last Update Posted:
2017-03-28
First Post:
2011-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Treatment of RFA and Sorafenib on Recurrent HCC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}, {'id': 'D000077157', 'term': 'Sorafenib'}], 'ancestors': [{'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D010671', 'term': 'Phenylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009536', 'term': 'Niacinamide'}, {'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 430}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-27', 'studyFirstSubmitDate': '2011-11-09', 'studyFirstSubmitQcDate': '2011-11-10', 'lastUpdatePostDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time interval between new lessions emerging after the first HCC recurrence', 'timeFrame': '3 year'}], 'secondaryOutcomes': [{'measure': '3-year overrall survival', 'timeFrame': '3 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['HCC', 'Radiofrequency Ablation', 'Sorafenib']}, 'descriptionModule': {'briefSummary': 'RFA is a routaine treatment of recurrent HCC. Recently Sorafenib was reported to be a promising drug to treat late stage HCC. But few studies were related with its effectiveness on recurrent HCC. So the investigators hypothesized that combined RFA and Sorafenib might reduce the frequency of recurrence and improve the overall survival and disease free survial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* recurrent HCC after curative resection\n* without gender restriction\n* age between 18 to 75 years\n* The liver function showed no worse than Child-Pugh B\n* tumor nodes were less than 5cm and no more than 3 nodules\n\nExclusion Criteria:\n\n* Pregnancy patients\n* With extrahepatic tumor or lymphnode metastasis\n* Tumor invasion or thrombosis in portal vein,hepatic vein or inferior vena cava'}, 'identificationModule': {'nctId': 'NCT01470495', 'acronym': 'REPEAT', 'briefTitle': 'Combined Treatment of RFA and Sorafenib on Recurrent HCC', 'organization': {'class': 'OTHER', 'fullName': 'Southwest Hospital, China'}, 'officialTitle': 'Radiofrequency Ablation Plus Sorafenib Administration in Early Recurrent Hepatocellular Carcinoma: a Prospective Multicenter Cohort Trial (Repeat) Tumors for BCLC B Stage HCC Undergone Curative Hepatectomy', 'orgStudyIdInfo': {'id': 'swhb005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RFA+Sorafenib', 'description': 'to treat recurrent HCC both with RFA and Sorafenib', 'interventionNames': ['Other: RFA + Sorafenib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RFA group', 'description': 'To treat recurrent HCC with RFA', 'interventionNames': ['Other: RFA']}], 'interventions': [{'name': 'RFA + Sorafenib', 'type': 'OTHER', 'description': 'combined RFA and Sorafenib to treat recurrent HCC', 'armGroupLabels': ['RFA+Sorafenib']}, {'name': 'RFA', 'type': 'OTHER', 'description': 'treat Recurrent HCC with RFA', 'armGroupLabels': ['RFA group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400038', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'feng xiaobin, MD', 'role': 'CONTACT', 'email': 'fengxiaobin200708@yahoo.com.cn', 'phone': '+86-23-13228683243'}, {'name': 'feng xiaobin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institute of hepatobiliary surgery,southwest hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Xiaobin Feng, MD', 'role': 'CONTACT', 'email': 'fengxiaobin200708@aliyun.com', 'phone': '+86-2368765297'}], 'overallOfficials': [{'name': 'Kuansheng Ma, MD,Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southwest Hopstial'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southwest Hospital, China', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hunan Province Tumor Hospital', 'class': 'OTHER'}, {'name': 'Tang-Du Hospital', 'class': 'OTHER'}, {'name': 'Xijing Hospital', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Guangxi Medical University', 'class': 'OTHER'}, {'name': "First Affiliated Hospital Xi'an Jiaotong University", 'class': 'OTHER'}, {'name': 'Anhui Provincial Hospital', 'class': 'OTHER_GOV'}, {'name': 'Xiangya Hospital of Central South University', 'class': 'OTHER'}, {'name': 'Xinqiao Hospital of Chongqing', 'class': 'OTHER'}, {'name': 'Xinjiang Tumor Hospital', 'class': 'UNKNOWN'}, {'name': "People's Hospital of Guangxi Zhuang Autonomous Region", 'class': 'OTHER'}, {'name': 'Henan Cancer Hospital', 'class': 'OTHER_GOV'}, {'name': "People's Hospital of Sichuan", 'class': 'UNKNOWN'}, {'name': 'Huaxi Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Institute of hepatobiliary surgery,southwest hospital', 'investigatorFullName': 'feng xiaobin', 'investigatorAffiliation': 'Southwest Hospital, China'}}}}