Genotype-driven Weekly Irinotecan Liposomes in Combination With Capecitabine-based Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer

PHASE1RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

March 3, 2024

Primary Completion Date

January 31, 2025

Study Completion Date

October 31, 2025

Conditions
Rectal Cancer
Interventions
DRUG

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)."

Trial Locations (1)

Unknown

RECRUITING

Zhejiang Cancer Hospital, Hangzhou

All Listed Sponsors
lead

Zhejiang Cancer Hospital

OTHER