30
Participants
Start Date
March 3, 2024
Primary Completion Date
January 31, 2025
Study Completion Date
October 31, 2025
irinotecan liposomes+capecitabine
"Radiotherapy:IMRT DT 50Gy/25Fx. Capecitabine: 625mg/m2 bid po d1-5 qw. For patients are double sites mutant (GG+7/7 or AA+6/6 or GA+6/7),the intial dose of Irinotecan liposomes is 25mg/m2 weekly,for four weeks。 This study stratify cases by the 3+3 rule according to UGT1A1 \* 6 and UGT1A1 \* 28 phenotypes. Three cases were enrolled in each dose group, and if there was no DLT, they were promoted to the next dose group(an increase of 5mg/m2); If there is 1 case of DLT, 3 cases will be reenrolled in the same dose group. If there is no new occurrence of DLT, it will be promoted to the next dose group. Otherwise, the study will be terminated; If there are 2 cases of DLT, the study will be terminated, and the previous dose group will be the maximum tolerated dose (MTD)."
RECRUITING
Zhejiang Cancer Hospital, Hangzhou
Zhejiang Cancer Hospital
OTHER