This is an exploratory, single-armed, open label study on the efficacy and safety of sequential S-1 therapy after SOX in unresectable metastatic or locally advanced biliary system or periampullary cancer or pancreatic cancer patients. The primary endpoint is Objective response rate and secondary endpoint is progression free survival , overall survival ,1 year survival rate and safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
4-6 cycles SOX followed by S-1 monotherapy until disease progression S-1: 40\~60mg bid,po, d1\~14 (S-1:BSA \<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA\>1.5m2, 60mg bid) oxaliplatin:130mg/m2,iv drip for 2h,d1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGObjective response rate for SOX sequential S-1
The primary endpoint is objective response rate,which equals CR+PR.
Time frame: 1 years
Overall Survival
OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 3 months till death or lost
Time frame: 2 years
progression free survival
PFS means that from the first dose of treatment drug to disease progression or death or lost, the follow-up visit will be performed every 6 weeks till progression or death or lost
Time frame: 1 year
1 year survival rate
the follow-up visit of survival will be performed every 3 months till 1 year
Time frame: 1 year
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Time frame: 2 years
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