Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2026-01-27 @ 3:45 AM
Study NCT ID:
NCT01429961
Status:
UNKNOWN
Last Update Posted:
2011-09-07
First Post:
2011-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Palliative Chemotherapy With TS-1 and Oxaliplatin for Patients With Advanced Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-09-06', 'studyFirstSubmitDate': '2011-09-06', 'studyFirstSubmitQcDate': '2011-09-06', 'lastUpdatePostDateStruct': {'date': '2011-09-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to progression (TTP)', 'timeFrame': '2 years', 'description': 'The time from study enrollment to tumor progression or death'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '2 years', 'description': 'overall survival'}, {'measure': 'response rate', 'timeFrame': '2 years', 'description': 'response rate by RECIST 1.1'}, {'measure': 'toxicity', 'timeFrame': '2 years', 'description': 'toxicity according to NCI-CTCAE v.3.0'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Advanced Hepatocellular Carcinoma']}, 'referencesModule': {'references': [{'pmid': '29506478', 'type': 'DERIVED', 'citation': 'Lee DW, Lee KH, Kim HJ, Kim TY, Kim JS, Han SW, Oh DY, Kim JH, Im SA, Kim TY. A phase II trial of S-1 and oxaliplatin in patients with advanced hepatocellular carcinoma. BMC Cancer. 2018 Mar 5;18(1):252. doi: 10.1186/s12885-018-4039-9.'}]}, 'descriptionModule': {'briefSummary': 'Phase II trial of Palliative Chemotherapy with TS-1 and Oxaliplatin for Patients with Advanced Hepatocellular Carcinoma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* ECOG performance score of two or less\n* Child Pugh class A•\n* Histologically or cytologically confirmed HCC or clinical diagnosis of HCC when the following criteria are all met History of chronic hepatitis or cirrhosis of liver Typical features of HCC demonstrated in dynamic imaging studies, such as three phase computed tomography AFP level more than 200 ng/mL\n* presence of extrahepatic measurable lesion\n* no prior systemic therapy (excluding sorafenib)\n* adequate marrow, liver, kidney function\n* written informed consent\n\nExclusion Criteria:\n\n* prior systemic therapy (excluding sorafenib)\n* hypersensitivity to study drugs\n* active gastrointestinal bleeding\n* other malignancies within five years\n* pregnant or breastfeeding female\n* symptomatic brain or leptomeningeal metastasis\n* clinically significant heart disease\n* interstitial pneumonia\n* peripheral neuropathy grade one or more\n* uncontrolled infection\n* renal impairment\n* prior use of investigational drug or therapy within 4 weeks'}, 'identificationModule': {'nctId': 'NCT01429961', 'briefTitle': 'Trial of Palliative Chemotherapy With TS-1 and Oxaliplatin for Patients With Advanced Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Phase II Trial of Palliative Chemotherapy With TS-1 and Oxaliplatin for Patients With Advanced Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'H-1010-054-336'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SOX', 'description': 'TS-1, Oxaliplatin regimen (3week) Oxaliplatin 130 mg/m2 IV Day 1 S-1 40 mg/m2 b.i.d. Day1-14', 'interventionNames': ['Drug: SOX']}], 'interventions': [{'name': 'SOX', 'type': 'DRUG', 'description': 'TS-1, Oxaliplatin regimen (3week) Oxaliplatin 130 mg/m2 IV Day 1 S-1 40 mg/m2 b.i.d. Day1\\~14', 'armGroupLabels': ['SOX']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Tae-You Kim', 'role': 'CONTACT', 'phone': '+82-2-2072-3943'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Tae-You Kim, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'kimty@snu.ac.kr', 'phone': '+82-2-2072-3943'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}