Actively Recruiting
Neoadjuvant Toripalimab With or Without Celecoxib in dMMR/MSI-H Colorectal Cancer
Led by Sun Yat-sen University · Updated on 2025-11-20
270
Participants Needed
1
Research Sites
568 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Colorectal cancer of Mismatch Repair-deficient (dMMR)/ Microsatellite Instability-high (MSI-H) accounts for approximately 15% of all colorectal cancer patients, with a higher proportion in right colon cancer. Previous studies have found that colon cancer patients with dMMR/MSI-H cannot benefit from 5-fluorouracil (5-FU) adjuvant chemotherapy. Once patients have distant metastases, they are not sensitive to traditional palliative chemotherapy, and the prognosis is significantly worse than that of mismatch repair-proficient (pMMR)/microsatellite stability (MSS). A phase II clinical study of anti-PD-1 immunotherapy based on mismatch repair (MMR) status published in 《N Engl J Med》 showed that the objective response rate (ORR) of advanced colorectal cancer patients with dMMR received anti-PD-1 is 40%, and a longer response time can be obtained compared to conventional chemotherapy. Anti-PD-1 neoadjuvant therapy has proven to be safe and feasible in lung cancer, bladder cancer and malignant melanoma, and can achieve more than 40% of major pathological response. However, there are no reports of anti-PD-1 neoadjuvant therapy for the dMMR/MSI-H colorectal cancer. Therefore, the aim of this study was to find the best multidisciplinary treatment for resectable colorectal cancer patient with the dMMR/MSI-H phenotype and to explore whether cyclooxygenase (COX) inhibitors combined with anti-PD-1 monoclonal antibody (mAb) could further improve efficacy.
CONDITIONS
Official Title
Neoadjuvant Toripalimab With or Without Celecoxib in dMMR/MSI-H Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent.
- Histological or cytological documentation of adenocarcinoma of the colon or rectum.
- Tumor tissues identified as mismatch repair-deficient (dMMR) by immunohistochemistry or microsatellite instability-high (MSI-H) by PCR.
- Male or female subjects aged 18 to 75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- CT or MRI scans within 14 days showing locally advanced (cT3-4 or cN1-2) cancer.
- Non complicated primary tumor (no obstruction, perforation, or bleeding).
- No previous systemic anticancer therapy for colorectal cancer.
- Adequate bone marrow, liver, and kidney function based on lab tests within 7 days before treatment.
You will not qualify if you...
- Previous or concurrent cancer distinct from colorectal cancer within 5 years before randomization.
- Significant cardiovascular disease including unstable angina or heart attack within 6 months before treatment.
- Heart failure grade III or IV.
- Unresolved toxicity higher than Grade 1 from any prior therapy.
- Known allergy to study drugs or their components.
- Current or recent (within 4 weeks) participation in another investigational drug study.
- Pregnant or breastfeeding women.
- Lack of effective contraception.
- Previous treatment with anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies, or other T cell checkpoint therapies.
- Presence of any distant metastasis.
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510655
Actively Recruiting
Research Team
Y
Yanhong Deng, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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