Actively Recruiting
Serplulimab Combined With CAPEOX + Celecoxib as Neoadjuvant Treatment for Locally Advanced Rectal Cancer
Led by Zhejiang University · Updated on 2026-03-05
50
Participants Needed
1
Research Sites
201 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Serplulimab Combined With CAPEOX + Celecoxib as Neoadjuvant Treatment for Locally Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent.
- Male or female subjects 18 to 75 years of age.
- Histological or cytological confirmation of adenocarcinoma of the rectum.
- No previous systemic anticancer therapy for rectal cancer.
- Tumor lower margin less than 10 cm from the anus verge.
- Tumor staging cT2N1-2M0, cT3N0-2M0, or cT4N0-2M0 MSS with MRF(-) by MRI.
- Primary tumor detectable by CT or MRI.
- ECOG performance status of 0 or 1.
- Eligible tumor tissues identified for MSI/MMR assays.
- Hepatitis B Surface Antigen (HBsAg) negative.
- If HBsAg positive, HBV-DNA less than 2500 copies/mL or 500 IU/mL.
- Hepatitis C antibody negative or HCV-RNA negative with liver enzymes ≤3×ULN.
- Patients with both hepatitis B and C infections are excluded.
You will not qualify if you...
- Recurrent rectal cancer or history of pelvic radiotherapy.
- History of inflammatory bowel disease.
- AIDS-related illnesses or known HIV infection.
- Preparing for or previously received organ or bone marrow transplant.
- Myocardial infarction or poorly controlled arrhythmias within 6 months.
- Severe cardiac insufficiency or left ventricular ejection fraction below 50%.
- Poorly controlled hypertension or history of hypertensive crisis.
- Major surgery within 28 days prior to enrollment.
- Previous treatment with immune checkpoint inhibitors.
- Participation in another clinical study within 14 days prior to this study.
- Uncontrolled tumor-related pain.
- Severe allergy to monoclonal antibodies.
- Allergy or intolerance to oxaliplatin or capecitabine ingredients.
- Pregnant or lactating women.
- Other factors that may lead to early study termination as determined by investigators.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Second Affiliated Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
K
Kefeng Ding, doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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