Colorectal cancer of Mismatch Repair-proficient (pMMR)/ Microsatellite Stability (MSS) accounts for approximately 85% of all colorectal cancer patients, which might be insensitive to immunotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy, such as CAPEOX regimen, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Celecoxib, a COX-2 inhibitor, can improve the immune microenvironment and have a potential to synergy with immunotherapy. Chemotherapy can improve the immunogenicity of cancer cells that might enhance the efficacy of immunotherapy. The aim of this study is to explore whether chemotherapy and cyclooxygenase (COX) inhibitors combined with anti-PD-1 monoclonal antibody (mAb) could improve efficacy for resectable colorectal cancer patient with the pMMR/MSS phenotype.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Serplulimab is an innovative monoclonal antibody targeting PD-1, developed by Shanghai Henlius Biotech, Inc. 300 mg, q3w. For the timing of serplulimab, there is a subgroup developed, all enrolled patients will be divided into 2 subgroups in 1:1 ratio, the fasting group and the control group. For the fasting group patients, fasting starts from 8 p.m. the day before treatment and concludes at 12 p.m. on the treatment day, water is allowed. For the control group patients, they have meals according to their habits.
Given PO
Given IV
celebrex
Second Affiliated Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGPathological complete response rates
Proportion of patients experiencing a pCR to perioperative PD-1 antibody
Time frame: 1 year
Major pathological response rates
The proportion of patients experiencing a major pathological response to perioperative PD-1 antibody
Time frame: 1 year
Rate of clinical complete response rate (cCR)
Proportion of patients experiencing a cCR to perioperative PD-1 antibody
Time frame: 1 year
R0 resection rates
The proportion of patients achieved a complete resection with negative margin
Time frame: 1 year
Treatment-related adverse events.
Assessed by evaluation of treatment-related adverse events.
Time frame: 1 year
Detection of MRD
To detect ctDNA in peripheral blood before and after treatment
Time frame: 1year
single cell sequence
Use single cell sequence to describe changes in the microenvironment of rectal cancer before and after treatment
Time frame: 1year
Disease Free Survival
Defined as the interval from enrollment to locoregional or metastatic recurrence or the appearance or a secondary colorectal cancer or death, whichever occurs first
Time frame: 3years
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