Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-29 @ 1:20 AM
Study NCT ID:
NCT01259193
Status:
UNKNOWN
Last Update Posted:
2011-04-14
First Post:
2010-12-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of Sorafenib and Zoledronic Acid to Treat Advanced 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077157', 'term': 'Sorafenib'}, {'id': 'D000077211', 'term': 'Zoledronic Acid'}], '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': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-04-13', 'studyFirstSubmitDate': '2010-12-13', 'studyFirstSubmitQcDate': '2010-12-13', 'lastUpdatePostDateStruct': {'date': '2011-04-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'numbers of adverse events', 'timeFrame': '1 year', 'description': 'to evaluate the toxicity of sorafenib in combination with zoledronic acid'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS), time to progression (TTP)', 'timeFrame': '1 year', 'description': 'to evaluate the efficacy of sorafenib in combination with zoledronic acid'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hepatocellular Carcinoma', 'Sorafenib', 'Zoledronic Acid', 'toxic reaction'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'Sorafenib ,an oral multikinase inhibitor targeting several tyrosine-kinase receptors with antiangiogenesis and antiproliferation of HCC, is the first approved target therapy for HCC.\n\nZoledronic acid is used for treatment of bone metastasis of diverse malignant cancer. Emerging data suggest that zoledronic acid may also exhibit anticancer properties.\n\nThe objectives of the study is to evaluate the safety of Sorafenib combined with Zoledronic Acid and to evaluate overall survival and time to progression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years\n* Hepatocellular carcinoma confirmed with pathology or identified with radiological images with typical features\n* patient with unresectable primary hepatocellular carcinoma\n* Child-Pugh Class A or B, score ≤ 7\n* ECOG score 0-2\n* Expected survival time not less than 12 weeks\n* At least one tumor nodule with one uni-dimension of ≥ 1 cm\n* Peripheral platelet of or more than 50×10(9)/L\n* Peripheral hemoglobin of or more than 85g/L\n* Peripheral albumen of or more than 28g/L\n* Total bilirubin ≤3.0mg/dl\n* ALT and AST ≤ 5.0 x the upper limit of normal\n* Serum amylase ≤ 1.5x the upper limit of normal\n* Serum creatinine ≤ 1.5x upper limit of normal\n* PT-INR\\<2.3 or PT prolong no more than 4s of normal\n\nExclusion Criteria:\n\n* Congestive heart failure \\> NYHA class 2\n* History of active coronary disease( except myocardial infarction more than 6 months ago)\n* Receive anti-arrhythmia treatment(except β-receptor blocker,calcium channel blocker and digoxin)\n* uncontrollable hypertension\n* Active clinically serious infections (\\> 2 NCI-CTC Version 3.0)\n* History of HIV infection\n* Inclined to hemorrhage or active hemorrhage with 1 month\n* Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in this study\n* Pregnant or breast-feeding.Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to enrolling in this portion of the study\n* Known or suspected allergy to any agent given in association with this trial\n* Concomitant anti-cancer therapy (except immunotherapy and Chinese traditional treatment)\n* Surgical operation within 4 weeks prior to enrolling in this portion of the study"}, 'identificationModule': {'nctId': 'NCT01259193', 'briefTitle': 'Clinical Study of Sorafenib and Zoledronic Acid to Treat Advanced HCC', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Phase II Study of Sorafenib and Zoledronic Acid in Advanced HCC', 'orgStudyIdInfo': {'id': 'SRFB-021'}, 'secondaryIdInfos': [{'id': 'LCI-10-10-20'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sorafenib and Zoledronic Acid', 'interventionNames': ['Drug: Sorafenib and Zoledronic Acid']}], 'interventions': [{'name': 'Sorafenib and Zoledronic Acid', 'type': 'DRUG', 'description': 'Sorafenib ,tablet,400mg Bid ,until patient can not tolerance Zoledronic Acid ,powder for injection,4mg per 3 week for 1 year', 'armGroupLabels': ['Sorafenib and Zoledronic Acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zheng-Gang Ren, Ph.D', 'role': 'CONTACT', 'email': 'ren.zhenggang@zs-hospital.sh.cn', 'phone': '0086-021-64041990', 'phoneExt': '2137'}, {'name': 'Lan Zhang, Master', 'role': 'CONTACT', 'email': 'zhang.lan@zs-hospital.sh.cn', 'phone': '0086-021-64041990', 'phoneExt': '2171'}, {'name': 'Zheng-Gang Ren, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jubo Zhang, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Liver Cancer Institute', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Zheng-Gang Ren, Ph.D', 'role': 'CONTACT', 'email': 'ren.zhenggang@zs-hospital.sh.cn', 'phone': '0086-021-64041990', 'phoneExt': '2149'}, {'name': 'Lan Zhang, Master', 'role': 'CONTACT', 'email': 'zhang.lan@zs-hospital.sh.cn', 'phone': '0086-021-64041990', 'phoneExt': '2171'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Ren Zhenggang/Professor Sun Huichuan/Professor', 'oldOrganization': 'Shanghai Zhongshan Hospital,China'}}}}