Trial of Palliative Chemotherapy With TS-1 and Oxaliplatin for Patients With Advanced Hepatocellular Carcinoma

Phase 2

• Conditions: Advanced Hepatocellular Carcinoma
• Interventions: Drug: SOX

• Registration Number: NCT01429961
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Phase II trial of Palliative Chemotherapy with TS-1 and Oxaliplatin for Patients with Advanced Hepatocellular Carcinoma

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-05
• Status Verified: 2011-09
• Study First Submitted: 2011-09-06
• Study First Submitted QC: 2011-09-06
• Last Update Submitted: 2011-09-06
• Study First Posted: 2011-09-07
• Last Update Posted: 2011-09-07
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Age 18 years or older
• 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

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Exclusion Criteria

• prior systemic therapy (excluding sorafenib)
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SOX	SOX	TS-1, Oxaliplatin regimen (3week) Oxaliplatin 130 mg/m2 IV Day 1 S-1 40 mg/m2 b.i.d. Day1-14

Primary Outcome Measures

Name	Time	Method
Time to progression (TTP)	2 years	The time from study enrollment to tumor progression or death

Secondary Outcome Measures

Name	Time	Method
response rate	2 years	response rate by RECIST 1.1
toxicity	2 years	toxicity according to NCI-CTCAE v.3.0
overall survival	2 years	overall survival

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of