Study of Dihydropyrimidine Dehydrogenase for Predicting Efficacy and Safety to S-1 Plus Oxaliplatin in Gastrointestinal Cancer
A new oral DPD inhibitory fluoropyrimidine (DIF), S-1, is reportedly effective against
gastrointestinal carcinoma. In this study, the relationship between activity of DPD in
peripheral blood and the effects of chemotherapy were investigated in 200 patients treated
with first-line S-1 combined with platinum chemotherapy for gastrointestinal carcinoma.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective tumor response
Tumor response was evaluated by RECIST 1.1. The relationship between DPD activity and the objective tumor response will be evaluated by Cox's proportional hazards regression model.
Every eight weeks
WENCHAO LIU, professor
xijing hospital of the fourth military medical univercity
China: Food and Drug Administration