Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-02-27 @ 1:09 AM
Study NCT ID:
NCT03239158
Status:
COMPLETED
Last Update Posted:
2019-01-25
First Post:
2017-08-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioinformation Therapy for Liver Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003452', 'term': 'Cryosurgery'}, {'id': 'D018274', 'term': 'Electroporation'}], 'ancestors': [{'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D055664', 'term': 'Electrochemical Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2018-09-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-23', 'studyFirstSubmitDate': '2017-08-01', 'studyFirstSubmitQcDate': '2017-08-01', 'lastUpdatePostDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relief degree of tumors', 'timeFrame': '3 months', 'description': 'It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）'}], 'secondaryOutcomes': [{'measure': 'Progress free survival（PFS）', 'timeFrame': '1 year', 'description': 'The duration between treatment and cancer recurrence'}, {'measure': 'Overall survival（OS）', 'timeFrame': '3 years', 'description': 'The duration between treatment and patient pass away'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer ablation', 'Life information rehabilitation therapy'], 'conditions': ['Liver, Cancer of, Non-Resectable']}, 'descriptionModule': {'briefSummary': 'The aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable liver cancer.', 'detailedDescription': 'By enrolling patients with unresectable liver cancer adapted to enrolled criteria, this study will document for the first time the synergistic effect of cancer ablation and life information rehabilitation therapy. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies\n* Body tumor 1-6, with at least one tumor length \\> 2 cm\n* KPS ≥ 70, lifespan \\> 6 months\n* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L\n\nExclusion Criteria:\n\n* Patients with cardiac pacemaker\n* Patients with brain metastasis\n* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction'}, 'identificationModule': {'nctId': 'NCT03239158', 'briefTitle': 'Bioinformation Therapy for Liver Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fuda Cancer Hospital, Guangzhou'}, 'officialTitle': 'Combination of Cancer Ablation and Life Information Rehabilitation Therapy for Unresectable Liver Cancer', 'orgStudyIdInfo': {'id': 'Bioinformation-liver'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cancer ablation', 'description': 'In this group, the patients will receive ablation therapy (e.g. cryosurgery or irreversible electroporation) first for big tumors (\\> 2 cm). The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).', 'interventionNames': ['Device: Cancer ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Life information rehabilitation therapy', 'description': 'In this group, the patients will drink "Qilisheng" Immunoregulatory Oral Solution for consecutive 3 months. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).', 'interventionNames': ['Drug: Life information rehabilitation therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Combination therapy', 'description': 'In this group, the patients will receive the combination therapy including ablation and life information rehabilitation therapy. The ablation therapy (e.g. cryosurgery or irreversible electroporation) will be performed first for big tumors (\\> 2 cm), then "Qilisheng" Immunoregulatory Oral Solution will be provided for consecutive 3 months. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).', 'interventionNames': ['Device: Cancer ablation', 'Drug: Life information rehabilitation therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'In this group, the patients will receive no special treatment and as a control group. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell).'}], 'interventions': [{'name': 'Cancer ablation', 'type': 'DEVICE', 'otherNames': ['Cryoablation or irreversible electroporation'], 'description': 'Tumors bigger than 2 cm are fit for ablation therapy, percutaneously under CT scan or ultrasound.', 'armGroupLabels': ['Cancer ablation', 'Combination therapy']}, {'name': 'Life information rehabilitation therapy', 'type': 'DRUG', 'otherNames': ['"Qilisheng" Immunoregulatory Oral Solution'], 'description': 'Each treatment: one bottle solution each day, consecutive 3 months, oral administration', 'armGroupLabels': ['Combination therapy', 'Life information rehabilitation therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510665', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Fuda cancer institute of Fuda cancer hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fuda Cancer Hospital, Guangzhou', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shengxin Biotechnology Institute, Beijing', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}