Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-01 @ 3:05 AM
Study NCT ID:
NCT03235167
Status:
UNKNOWN
Last Update Posted:
2017-09-18
First Post:
2017-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cytidine-phosphate-guanosine (CpG) DNA in Hepatocellular Carcinoma Combination Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-14', 'studyFirstSubmitDate': '2017-07-27', 'studyFirstSubmitQcDate': '2017-07-27', 'lastUpdatePostDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'survival time', 'timeFrame': '5 years'}, {'measure': 'metastasis free survival time', 'timeFrame': '5 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'to observe the outcome of hepatocellular carcinoma patients under the combination treatment of transcatheter arterial chemoembolization (TACE) and CpG DNA'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* TNM (tumor node metastasis ) staging with non distant metastasis; no other tumors\n\nExclusion Criteria:\n\n* having received previous treatment for liver cancer'}, 'identificationModule': {'nctId': 'NCT03235167', 'briefTitle': 'Cytidine-phosphate-guanosine (CpG) DNA in Hepatocellular Carcinoma Combination Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Dalian University'}, 'officialTitle': 'Cytidine-phosphate-guanosine (CpG) DNA in Hepatocellular Carcinoma Combination Therapy', 'orgStudyIdInfo': {'id': 'zsyy_zxsys2017-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CpG DNA', 'description': 'CpG DNA concentrate', 'interventionNames': ['Drug: CpG DNA', 'Procedure: transcatheter arterial chemoembolization']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo concentrate', 'interventionNames': ['Procedure: transcatheter arterial chemoembolization', 'Drug: Placebo - Concentrate']}], 'interventions': [{'name': 'CpG DNA', 'type': 'DRUG', 'description': 'CpG DNA concentrate', 'armGroupLabels': ['CpG DNA']}, {'name': 'transcatheter arterial chemoembolization', 'type': 'PROCEDURE', 'description': 'transcatheter arterial chemoembolization (TACE) therapy for liver cancer', 'armGroupLabels': ['CpG DNA', 'placebo']}, {'name': 'Placebo - Concentrate', 'type': 'DRUG', 'description': 'CpG DNA vehicle', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'haoren wang', 'role': 'CONTACT', 'email': 'haoren_wang@yahoo.com', 'phone': '86-041162893507'}], 'overallOfficials': [{'name': 'xiaolin Yuan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Affiliated Zhongshan Hospital of Dalian University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'age, gender, cancer staging'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dalian University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}