The goal of this clinical trial is to compare the efficacy and safety of the combination of immune checkpoint inhibitors (ICIs) and FOLFOX regimen compared to FOLFOX regimen alone in the neoadjuvant chemotherapy of locally advanced colorectal cancer. The main question aims to answer are: Question 1: Compare the pathological complete response rate between the combination of ICIs and FOLFOX regimen and the FOLFOX alone. Question 2: Compare the survival outcomes and safety between the combination of ICIs and FOLFOX regimen and the FOLFOX alone. Two groups of participants will receive different new adjuvant chemotherapy regimens, and their efficacy will be compared.
A prospective, randomized, open, multi-center clinical study evaluating the efficacy (pathological response, survival outcomes) and safety of the combination of ICIs and FOLFOX regimen compared to FOLFOX regimen in the treatment of locally advanced colorectal cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
170
PD-1 antibody
FOLFOX chemotherapy
Cancer Hospital/ National Cancer Center, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGQilu Hospital of Shandong University
Jinan, Shandong, China
RECRUITINGpCR rate
pathological complete response rate
Time frame: at time of surgery
R0 resection rate
R0 resection rate
Time frame: at time of surgical assessment (after 3 cycles), up to 12 months
DFS
disease-free survival
Time frame: up to 3 years after intervention
3 years DFS rate
3 years DFS rate
Time frame: 3 years
OS
overall survival
Time frame: at 1,2,3 years at follow-up time
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