NCT01533324

S-1/LV One Week on and One Week Off Regimen in Advanced Hepatocellular Carcinoma (HCC)

Phase II Study of S-1 Combined With Calcium Folinate to Treat Advanced Hepatocellular Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Second Military Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

S-1 is a new chemotherapy drug. Some phase II trials showed S-1 is effective in Hepatocellular Carcinoma (HCC). S-1 combined with calcium folinate (SL) showed very good efficiency and safety in colorectal cancer (CRC). The short duration (two weekly regimen) is better than common course 4 week regimen in tolerance. So the investigators want to examine the efficiency and safety of SL one week on and one week off regimen in HCC.

Detailed description

S-1 is a new chemotherapy drug. Some phase II trials showed S-1 is effective in HCC. S-1 combined with calcium folinate (SL) showed very good efficiency and safety in CRC. The short duration (two weekly regimen) is better than common course 4 week regimen in tolerance. So the investigators want to examine the efficiency and safety of SL one week on and one week off regimen in HCC. SL one week on and one week off regimen will be give to advanced HCC patients. The primary endpoint is durable complete response (DCR).

Conditions

• Carcinoma
• Liver Diseases
• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	S-1 combined with Leucovorin	S-1 capsules 80mg/m2/d BID one week on and one week off Leucovorin tablets 50mg/d BID one week on and one week off

Timeline

• Start date: 2011-11-01
• Primary completion: 2016-11-01
• Completion: 2016-12-01
• First posted: 2012-02-15
• Last updated: 2012-02-15

Locations

1 site across 1 country: China