Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-03 @ 8:27 PM
Study NCT ID:
NCT03178656
Status:
UNKNOWN
Last Update Posted:
2017-12-21
First Post:
2017-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial to Compare Surgery With Sorafenib for Hepatic Celluler Cancer With Portal Vein Tumor Thrombosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077157', 'term': 'Sorafenib'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D053221', 'term': 'TNF-Related Apoptosis-Inducing Ligand'}], 'ancestors': [{'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'}, {'id': 'D048069', 'term': 'Tumor Necrosis Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2019-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-19', 'studyFirstSubmitDate': '2017-05-31', 'studyFirstSubmitQcDate': '2017-06-05', 'lastUpdatePostDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'mortality', 'timeFrame': '30 days', 'description': 'death within 30 days after surgery'}], 'primaryOutcomes': [{'measure': 'overall survival of 1 year', 'timeFrame': '1 years', 'description': 'including 3, 6, and 12 months overall survival (OS) rate'}, {'measure': 'overall survival of 3 year', 'timeFrame': '3 years', 'description': 'including 1, 2, and 3 years overall survival (OS) rate'}], 'secondaryOutcomes': [{'measure': 'time to progression', 'timeFrame': '3 years', 'description': 'deterioration indicated by complications or metastasis detected by CT, MRI and laboratory examination.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sorafenib, operation'], 'conditions': ['Portal Vein Tumor Thrombus']}, 'descriptionModule': {'briefSummary': "According to the guidelines recommended, only a few new targeted therapy drugs treatment, such as Sorafenib, is proper. It's 3 year survival rate is only 8% or so. According to our previous study, patients with hepatic carcinoma without portal vein tumor thrombus backbone and the contralateral tumor thrombus applyed tumor excision, along with tumor thrombus, the 3 year survival rate can reach 39.9%, the 5-year survival rate can reach 22.7%, curative effect is obviously better."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Clinical diagnosis of Hepatic cellular Carcinoma. 2. Patients with Portal Vein Tumor Thrombus (PVTT) of Hepatic cellular Carcinoma (HCC) detected by Serum Alpha Fetoprotein (AFP) and CT or MRI.\n\n 3\\. Patients with a solitary tumor or multiple tumor which are resectable. 4. Patients without Hepatic vein or bile duct invasion and extrahepatic metastasis.\n\n 5\\. Patients without surgical contraindication. 6. Patients with Child A or B liver function and indocyanine green retention rate at 15min (ICGR15) \\< 10% before treatment.\n\n 7\\. Laboratory examination: haemoglobin (Hb)\\>100g/L, white blood cell (WBC) \\> 3000/mL, PLT \\> 8×10\\*10/L before treatment.\n\n 8\\. Patients without severe esophagealgastric varices before treatment. 9. Patients with HBV，HBV DNA≤100, 000 copy/mL. 10. All of the patients has written consent for this research.\n\nExclusion Criteria:\n\n* 1.Patients with multiple tumors or vascular or bile duct invasion or extrahepatic metastasis.\n\n 2.Patients with surgical contraindication. 3.Patients with Child C grade liver function before treatment. 4.Patients with other malignancy. 5.Patients treated with hepatic resection or TACE before this treatment. 6.Patients with severe esophagealgastric varices or refractory ascites or coagulation dysfunction before treatment.'}, 'identificationModule': {'nctId': 'NCT03178656', 'briefTitle': 'A Trial to Compare Surgery With Sorafenib for Hepatic Celluler Cancer With Portal Vein Tumor Thrombosis', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'RCT Research: the Treatment of Hepatic Carcinoma With Portal Vein Branch Tumor Thrombosis (Resection or Sorafenib)', 'orgStudyIdInfo': {'id': 'chenxp007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PVTT WITH SORAFENIB', 'description': 'AASLD recommend therapy:\n\nsorafenib tablet, 400mg, bid.', 'interventionNames': ['Drug: Sorafenib']}, {'type': 'EXPERIMENTAL', 'label': 'PVTT WITH OPERATION', 'description': 'patients suitable for surgery', 'interventionNames': ['Procedure: surgery']}], 'interventions': [{'name': 'Sorafenib', 'type': 'DRUG', 'otherNames': ['control'], 'description': 'continuous application of the drugs', 'armGroupLabels': ['PVTT WITH SORAFENIB']}, {'name': 'surgery', 'type': 'PROCEDURE', 'otherNames': ['trail'], 'description': 'curative resection', 'armGroupLabels': ['PVTT WITH OPERATION']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoping Chen, Doctor', 'role': 'CONTACT', 'email': 'chenxp@medmail.com.cn', 'phone': '8602783662851'}, {'name': 'Qiong Gong, Doctor', 'role': 'CONTACT', 'email': 'dtjgq486@hust.edu.cn', 'phone': '8618086496360'}, {'name': 'peng zhu, doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hepatic surgery center, Tong ji Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Qiong Gong, Doctor', 'role': 'CONTACT', 'email': 'dtjgq486@hust.edu.cn', 'phone': '+8618086496360'}, {'name': 'Xiaoping Chen, Doctor', 'role': 'CONTACT', 'email': 'chenxp@medmail.com.cn', 'phone': '+862783665253'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xiaoping Chen', 'investigatorAffiliation': 'Huazhong University of Science and Technology'}}}}