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

Seoul National University

Status and phase: Unknown; Phase 2

Conditions: Advanced Hepatocellular Carcinoma

Treatments: Drug: SOX

Study type: Interventional

Funder types: Other

Identifiers

NCT01429961

H-1010-054-336

Details and patient eligibility

About

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

Enrollment: 38 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

SOX

Experimental group

Description:

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

Treatment:

Drug: SOX