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

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Oxaliplatin

Criteria

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