Status:
UNKNOWN
Trial of Palliative Chemotherapy With TS-1 and Oxaliplatin for Patients With Advanced Hepatocellular Carcinoma
Lead Sponsor:
Seoul National University Hospital
Conditions:
Advanced Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Phase II trial of Palliative Chemotherapy with TS-1 and Oxaliplatin for Patients with Advanced Hepatocellular Carcinoma
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01429961
Start Date
May 1 2011
End Date
December 1 2013
Last Update
September 7 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Seoul National University Hospital
Seoul, South Korea, 110-744