RecruitingPhase 2NCT05731726

Serplulimab Combined With CAPEOX + Celecoxib as Neoadjuvant Treatment for Locally Advanced Rectal Cancer

A Phase II Study to Explore the Neoadjuvant Treatment of Serplulimab Combined With CAPEOX + Celecoxib in the Treatment of Locally Advanced Rectal Cancer


Sponsor

Zhejiang University

Enrollment

50 participants

Start Date

Feb 22, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a combination of treatments before surgery (called neoadjuvant therapy) for people with locally advanced rectal cancer. The combination includes an immunotherapy drug called serplulimab, two chemotherapy drugs (capecitabine and oxaliplatin, known as CAPEOX), and celecoxib (an anti-inflammatory medicine). The goal is to shrink the tumour before surgery and improve long-term outcomes. **You may be eligible if...** - You are 18 to 75 years old - You have been diagnosed with rectal cancer confirmed by biopsy - Your cancer has not spread to other parts of the body (non-metastatic) - You have not had any previous cancer treatment for this rectal cancer - Your tumour is within 10 cm of the anal opening - You are in good general health **You may NOT be eligible if...** - Your rectal cancer has come back after previous treatment, or you have had pelvic radiation before - You have inflammatory bowel disease (such as Crohn's or ulcerative colitis) - You have HIV, or both hepatitis B and C infections - You have had an organ or bone marrow transplant - You have a significant heart condition (such as a recent heart attack, severe heart failure, or poorly controlled blood pressure) - You have had major surgery in the past 4 weeks - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSerplulimab

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.

DRUGCapecitabine

Given PO

DRUGOxaliplatin

Given IV

DRUGCelecoxib

celebrex


Locations(1)

Second Affiliated Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, China

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NCT05731726


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