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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
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
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGDCR
DCR means patient got the best reaction and last for more than 4 weeks DCR=(CR)+ (PR)+ (SD) by RESIST 1.1
Time frame: in two years
TTP ( time to progression)
from enrolled to progression(iconography).
Time frame: in 2 years
OS ( overall survival)
to death
Time frame: in two years
safety
any adverse reaction by NCI-CTCAE 3.0
Time frame: in two years
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