Trial of Palliative Chemotherapy With TS-1 and Oxaliplatin for Patients With Advanced Hepatocellular Carcinoma
NCT ID: NCT01429961
Last Updated: 2011-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
38 participants
INTERVENTIONAL
2011-05-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SOX
TS-1, Oxaliplatin regimen (3week) Oxaliplatin 130 mg/m2 IV Day 1 S-1 40 mg/m2 b.i.d. Day1-14
SOX
TS-1, Oxaliplatin regimen (3week) Oxaliplatin 130 mg/m2 IV Day 1 S-1 40 mg/m2 b.i.d. Day1\~14
Interventions
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SOX
TS-1, Oxaliplatin regimen (3week) Oxaliplatin 130 mg/m2 IV Day 1 S-1 40 mg/m2 b.i.d. Day1\~14
Eligibility Criteria
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Inclusion Criteria
* ECOG performance score of two or less
* Child Pugh class A•
* 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
* presence of extrahepatic measurable lesion
* no prior systemic therapy (excluding sorafenib)
* adequate marrow, liver, kidney function
* written informed consent
Exclusion Criteria
* hypersensitivity to study drugs
* active gastrointestinal bleeding
* other malignancies within five years
* pregnant or breastfeeding female
* symptomatic brain or leptomeningeal metastasis
* clinically significant heart disease
* interstitial pneumonia
* peripheral neuropathy grade one or more
* uncontrolled infection
* renal impairment
* prior use of investigational drug or therapy within 4 weeks
18 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Tae-You Kim
Role: primary
References
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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.
Other Identifiers
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H-1010-054-336
Identifier Type: -
Identifier Source: org_study_id
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