Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-02-27 @ 4:41 AM
Study NCT ID:
NCT00644020
Status:
UNKNOWN
Last Update Posted:
2008-03-26
First Post:
2008-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase ⅡStudy of Tyroserleutide for Injection in Hepatocellular Carcinoma(HCC) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2018-11-16', 'releaseDate': '2018-04-17'}, {'resetDate': '2019-03-08', 'releaseDate': '2018-11-20'}], 'estimatedResultsFirstSubmitDate': '2018-04-17'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D012008', 'term': 'Recurrence'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016685', 'term': 'Mitomycin'}, {'id': 'D005472', 'term': 'Fluorouracil'}], 'ancestors': [{'id': 'D008937', 'term': 'Mitomycins'}, {'id': 'D045563', 'term': 'Indolequinones'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001389', 'term': 'Azirines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'collection of blood sample before the operation and ahead of the third and the sixth period.\n\ncollection of the tumor tissue during the operation'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2008-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-03-25', 'studyFirstSubmitDate': '2008-03-23', 'studyFirstSubmitQcDate': '2008-03-25', 'lastUpdatePostDateStruct': {'date': '2008-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DFS(disease free survival)', 'timeFrame': 'six month'}], 'secondaryOutcomes': [{'measure': '1.OS （Overall Survival） 2.QOL (quality of life)', 'timeFrame': 'six month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hepatocellular carcinoma', 'recurrence'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'The investigation is a randomized, double-blind, placebo involved and multi-center clinical trial. All subjects are assigned to 4 groups, including 3mg, 6mg, 12mg per day and placebo group. Each group includes 25 subjects, who have hepatic-cellular carcinoma accompanied with branch vein thrombosis. They receive investigational drug 40 days after resection surgery. Each cycle lasts 4 to 6 days with an interval of 29 days in all 6 cycles.', 'detailedDescription': '* Patients who have signed the Informed Consent Form and are eligible for the entry criteria will be randomly assigned to either the TYROSERLEUTIDE treatment group or the placebo group. No matter which group the subject is assigned, he/she would receive chemotherapy treatment through the portal vein pump which was transplanted during the carcinoma section surgery 40 days before the randomization.\n* Participants will be given either TYROSERLEUTIDE or placebo through intravenous injection with an interval of 29 days, during which the participant will not take any investigational drug or any other anti-tumor treatment as well. On the day just next to the completion of each cycle of research treatment which usually lasts for 3-5 days, the participant will receive medical inspection so as to observe and ensure drug safety.\n* Participants will continue to receive investigational drug for 6 cycles until being detected with recurrence or metastasis of tumor or experiencing any serious side effects.\n* A CT scan or MRI scan will be performed for each participant to exclude the recurrence or metastasis of tumor and assess the effects of treatment once before the initiation of each new cycle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'HCC complicating branch cork after resection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Written informed consent\n2. Age between 18 and 75 years\n3. Hepatocellular Carcinoma accompanied with branch vein thrombosis\n4. Carcinoma and bolt resection Integrity, cutting edge no tumor cells by microscopic lens in operation\n5. CTA or MRI no Carcinoma and bolt after operation\n\nExclusion Criteria:\n\n1. hypersensitivity to the composition similarity of investigational drug\n2. Concomitance other system primary tumor\n3. surface area 1.47m2～1.92m2\n4. HBV (-) and HCV(-)\n5. Patients who have received resectional surgery for HCC\n6. HCC complicating main portal vein cork\n7. HCC complicating hepatic vein cork\n8. Patients who have received systematicness therapy for HCC\n9. Patients who have received immunoregulant 4 weeks before randomization\n10. Concurrent participation in another clinical trial involving experimental treatment is excluded 4 weeks before randomization\n11. uncontrolled infection, hemorrhage, guts leakage postoperative complications\n12. postoperative liver function Child-pugh C\n13. no evidence of extra-hepatic metastases postoperative\n14. no utility sample for gene chip research\n15. no physical examination, laboratory and imageology examination that baseline request'}, 'identificationModule': {'nctId': 'NCT00644020', 'briefTitle': 'Phase ⅡStudy of Tyroserleutide for Injection in Hepatocellular Carcinoma(HCC) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shenzhen Kangzhe Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Randomized, Double Blind, Placebo Controled, Multicenter Phase ⅡStudy to Evaluate the Safety and Efficacy of Tyroserleutide for Injection in Hepatocellular Carcinoma(HCC) Patients', 'orgStudyIdInfo': {'id': 'TYS-CN-1.1PUMPⅡPartA'}, 'secondaryIdInfos': [{'id': 'TYS-CN-1.1PUMPⅡPartA'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'the Tyroserleutide for injection at the dosage of 3mg/d', 'interventionNames': ['Drug: mitomycin, Fluorouracil']}, {'label': 'Group 2', 'description': 'the Tyroserleutide for injection at the dosage of 6mg/d', 'interventionNames': ['Drug: mitomycin, Fluorouracil']}, {'label': 'Group 3', 'description': 'the Tyroserleutide for injection at the dosage of 12mg/d', 'interventionNames': ['Drug: mitomycin, Fluorouracil']}, {'label': 'Group 4', 'description': 'the placebo group', 'interventionNames': ['Drug: mitomycin, Fluorouracil']}], 'interventions': [{'name': 'mitomycin, Fluorouracil', 'type': 'DRUG', 'otherNames': ['mitomycin: serial numbers:071006', 'Fluorouracil: serial numbers:0710071'], 'description': 'All participants will receive 10mg mitomycin and 1g Fluorouracil through the chemoradiative pump which was transplanted during the operation, and this procedure would be executed a day before each research treatment period.', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weihua Jia, Professor', 'role': 'CONTACT', 'phone': '020-87343370'}, {'name': 'Yaqi Zhang, Professor', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'A Research Institute of Tumor', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Chen X P, professor', 'role': 'CONTACT', 'email': 'chenxp_53@sina.com', 'phone': '027-83662599'}], 'overallOfficials': [{'name': 'Chen X P, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tongji Medical College of Huazhong University of ScienceTechnology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenzhen Kangzhe Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Xiaoping Chen', 'oldOrganization': 'Tongji Hospital of Tongji Medical College of HUST'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-04-17', 'type': 'RELEASE'}, {'date': '2018-11-16', 'type': 'RESET'}, {'date': '2018-11-20', 'type': 'RELEASE'}, {'date': '2019-03-08', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Shenzhen Kangzhe Pharmaceutical Co., Ltd.'}}}}