Combination chemotherapy of sorafenib and S-1 in patients with advanced hepatocellular carcinoma: phase I trial
Phase 1
- Conditions
- Hepatocellular carcinoma
- Registration Number
- JPRN-UMIN000002418
- Lead Sponsor
- Kanazawa University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 21
Inclusion Criteria
Not provided
Exclusion Criteria
1) histrogically confirmed combined type hepatocellular carcinoma or sarcomatous change 2) previous therapy for hepatocellular carcinoma within 30 days 3) preceded chemotherapy used sorafenib or 5-FU (excluded transcatheter arterial embolization or adjuvant chemotherapy) 4) inadequate for administration of sorafenib or S-1 5) active double cancer 6) active infection (excluded viral hepatitis) 7) water diarrhea 8) severe complication 9) refractory ascites of pleural effusion 10) metastases to central nervous system 11) pregnancy or lactaing females 12) inappropriate for entry onto this study in the judgment of the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incident of dose-limiting toxicity
- Secondary Outcome Measures
Name Time Method Adverse events Response rate Time to progression Overall survival