Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-02-21 @ 12:19 AM
Study NCT ID:
NCT02018757
Status:
UNKNOWN
Last Update Posted:
2014-05-28
First Post:
2013-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Arsenic Trioxide Contained in TACE in the Treatment of HCC
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'lastUpdateSubmitDate': '2014-05-25', 'studyFirstSubmitDate': '2013-12-09', 'studyFirstSubmitQcDate': '2013-12-17', 'lastUpdatePostDateStruct': {'date': '2014-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to progression', 'timeFrame': 'From date of randomization until the date of first documented progression, up to 24 months'}], 'secondaryOutcomes': [{'measure': 'objective response rate', 'timeFrame': 'every 3 months from randomization until the date of first documented progression, up to 24 months', 'description': 'patients proportion of CR and PR according to mRECIST'}, {'measure': 'progression free survival', 'timeFrame': 'From date of randomization until the date of first documented progression, up to 24 months', 'description': 'survival from randomization to the date of first documented progression according to the mRECIST criterion'}, {'measure': 'overall survival', 'timeFrame': 'From date of randomization until the date of death from any cause, up to 60 months'}, {'measure': 'Proportion of Participants with Adverse Events', 'timeFrame': 'every 3 months from randomization until the date of first documented progression, up to 24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Carcinoma, Hepatocellular', 'primary liver cancer', 'primary hepatocellular carcinoma', 'transarterial chemoembolization', 'Chemoembolization, Therapeutic', 'arsenic trioxide', 'arsenous anhydride', 'diarsenic trioxide', 'randomized controlled trial', 'multicenter study', 'HCC', 'TACE'], 'conditions': ['Carcinoma, Hepatocellular']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether transarterial chemoembolization containing arsenic trioxide is safe and effective in the treatment of intermediate-stage hepatocellular carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* accordance with primary hepatocellular carcinoma diagnosis standard：cytohistology standard or non-invasive standard.1）+2）a or 1）+2）b+3）of the following are the non-invasive diagnosis criteria:(1)patients with HBV or HCV related liver cirrhosis.(2)radiological lesion(s) in liver with arterial hypervascularity and venous or delayed phase washout: a.one kind of imaging technology diagnosis for those with lesions\\>2cm;b.two kinds of imaging technology obtains the consistent conclusion for lesions with diameter of 1-2 cm.(3)serum AFP level ≥400 ug/L lasting for more than 1 month or ≥200 ug/L lasting for more than 2 months, other diseases that may cause the AFP level increase can be excluded,such as pregnancy, genital or embryonic tumors and active hepatitis.\n* age of 18 to 75 year,male or female\n* life expectancy of 12 weeks\n* Barcelona Clinic Liver Cancer (BCLC)stage B\n* laboratory tests:(1)leukocyte\\>3\\*19\\^9/L;(2)hemoglobin≥8.5g/dl;(3)platelet count ≥50\\*10\\^9/L,(4)ALT and AST were less than three times the normal limit;(5)albumin ≥ 3.0 g/dl;(6)total bilirubin acuities 3 mg/dl;(7)prothrombin time international standardization ratio (PT - INR) \\< = 2.3 or prothrombin time (PT)more than normal compared 3 seconds;(8)serum creatinine is less than 1.5 times the normal of the upper limit\n* patients with signed informed consent\n\nExclusion Criteria:\n\n* concomitant malignancies distinct from HCC currently or previously\n* allergic to subject agent(such as arsenic) or other agent related to the trial\n* BCLC stage 0,A,C or D\n* HCC accounting for the 70% of the liver size or more\n* liver function Child-Pugh score of C\n* ECOG score of 1 or higher\n* severe heart diseases,such as congestive heart failure with cardiac function of New York Heart Association(NYHA)functional class II or severe, active coronary disease(except for who with myocardial infarction for more than 6 months) and cardiac arrhythmia needing medical management(except for that controllable by β-blockers、calcium channel blockers and digoxin )\n* uncontrollable hypertension(diastolic blood pressure cannot be controlled below 90 mmHg even after antihypertension treatment by antihypertensive drugs).\n* active severe infection(grade 2 or higher according to NCI-CTCAE version 4.0)\n* active tuberculosis or pulmonary tuberculosis cannot be excluded\n* CNS malignancies, including intracranial metastases\n* gastrointestinal bleeding with clinical findings in the previous 30 days\n* chronic renal failure\n* pregnancy or breastfeeding\n* any other unstable conditions or circumstances possibly to jeopardise the safety or compliance of the subjects.'}, 'identificationModule': {'nctId': 'NCT02018757', 'acronym': 'SEATH', 'briefTitle': 'Safety and Efficacy of Arsenic Trioxide Contained in TACE in the Treatment of HCC', 'organization': {'class': 'OTHER', 'fullName': 'First Hospital of China Medical University'}, 'officialTitle': 'Clinical Application Study of Transarterial Chemoembolization Containing Arsenic Trioxide in the Treatment of Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': '2012AA022701'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'As2O3', 'description': 'Subjects will be treated with TACE containing As2O3', 'interventionNames': ['Drug: TACE containing As2O3']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Subjects will be treated with TACE containing placebo which mimics the arsenic trioxide', 'interventionNames': ['Drug: TACE containing placebo']}], 'interventions': [{'name': 'TACE containing As2O3', 'type': 'DRUG', 'otherNames': ['transarterial chemoembolization,TACE,As2O3,arsenious acid'], 'description': 'transarterial chemoembolization containing a mixture of 20mg of arsenic trioxide, 40mg of adriamycin and some dose of 40% ultra-fluid lipiodol', 'armGroupLabels': ['As2O3']}, {'name': 'TACE containing placebo', 'type': 'DRUG', 'description': 'transarterial chemoembolization containing a mixture of 20mg of placebo, 40mg of adriamycin and some dose of 40% ultra-fluid lipiodol', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Peihong Wu, MD,PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Gaojun Teng, MD,PhD', 'role': 'CONTACT'}, {'name': 'Gaojun Teng, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhongda Hospital Southeast University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '110001', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'contacts': [{'name': 'Haibo Shao, MD,PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'contacts': [{'name': 'Guohong Han, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Xijing Hospital，Fourth Military Medical University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': 'Shanghai', 'country': 'China', 'contacts': [{'name': 'Jianhua Wang, MD,PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhongshan Hospital Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Haibo Shao, MD,PHD', 'role': 'CONTACT', 'email': 'haiboshao@aliyun.com', 'phone': '862483282730'}], 'overallOfficials': [{'name': 'Haibo Shao, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Hospital of China Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Hospital of China Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sun Yat-sen University', 'class': 'OTHER'}, {'name': 'Zhongda Hospital', 'class': 'OTHER'}, {'name': 'Fudan University', 'class': 'OTHER'}, {'name': 'Xijing Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Haibo Shao', 'investigatorAffiliation': 'First Hospital of China Medical University'}}}}