About this trial
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.
Eligibility criteria
Qualifiers
Willing and able to provide written informed consent.
Male or female subjects ≧ 18 years ≦ 75 of age.
Histological or cytological documentation of adenocarcinoma of the rectum.
No previous any systemic anticancer therapy for rectal cancer disease.
Disqualifiers
Patients with recurrent rectal cancer or a history of pelvic radiotherapy.
Patients with a history of inflammatory bowel disease.
Patients with acquired immunodeficiency syndrome (AIDS-related illnesses) or known human immunodeficiency virus (HIV) disease (HIV1 antibody, HIV2 antibody, HTLV1 antibody positive) should be excluded.
Patients who are preparing for or have previously received an organ or bone marrow transplant.
Trial design
Treatments tested in this trial
- Serplulimab
- Capecitabine
- Oxaliplatin
- Celecoxib