Actively Recruiting
A Phase II Study to Explore the Neoadjuvant Treatment of Serplulimab Combined With CAPEOX + Celecoxib in Locally Advanced Rectal Cancer
Led by Zhejiang University · Updated on 2026-03-05
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a new treatment approach for patients with locally advanced rectal cancer that has a specific genetic profile called mismatch repair-proficient (pMMR) and microsatellite stable (MSS). This type of colorectal cancer makes up about 85% of cases and may not respond well to immunotherapy alone. The study, sponsored by Zhejiang University, aims to see if combining chemotherapy and a COX-2 inhibitor with an anti-PD-1 monoclonal antibody can improve treatment outcomes in these patients. Participants will receive a combination of serplulimab, an anti-PD-1 monoclonal antibody, given every three weeks at a dose of 300 mg, alongside the CAPEOX chemotherapy regimen, which includes oxaliplatin (130 mg/m2 intravenously on day 1) and capecitabine (1000 mg/m2 taken orally twice daily from days 1 to 14). They will also take celecoxib, a COX-2 inhibitor, orally twice daily from days 1 to 21. This treatment cycle repeats every three weeks for 4 to 8 cycles, followed by surgery to remove the tumor. Throughout the study, participants will be closely monitored with imaging scans and laboratory tests to assess tumor response and immune markers. Researchers will evaluate the rate of complete pathological response one year after treatment, along with other outcomes like clinical response, safety, and disease-free survival over three years. The total participation time includes the treatment period followed by surgery and long-term follow-up to assess the effectiveness and safety of the combination therapy.
CONDITIONS
Brief 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 aged 18 to 75 years.
- Histological or cytological confirmation of adenocarcinoma of the rectum.
- No prior systemic anticancer therapy for rectal cancer.
- Tumor lower margin less than 10 cm from the anus.
- Clinical staging of cT2N1-2M0, cT3N0-2M0, or cT4N0-2M0 MSS with MRF negative by MRI.
- Primary tumor detectable by CT or MRI.
- ECOG performance status of 0 or 1.
- Eligible tumor tissues identified for MSI/MMR assays.
- Negative for hepatitis B surface antigen or low HBV-DNA if positive.
- Negative for hepatitis C antibody or RNA, or controlled liver enzyme levels if RNA positive.
- Exclusion of patients co-infected with hepatitis B and C viruses.
You will not qualify if you...
- History of recurrent rectal cancer or prior pelvic radiotherapy.
- History of inflammatory bowel disease.
- AIDS-related illnesses or known HIV infection.
- Preparation for or prior organ or bone marrow transplant.
- Recent myocardial infarction or poorly controlled arrhythmias in past 6 months.
- Grade III-IV cardiac insufficiency or reduced heart ejection fraction below 50%.
- Poorly controlled hypertension or hypertensive crisis history.
- Major surgery within 28 days before enrollment, except biopsy or lymph node dissection.
- Previous treatment with immune checkpoint inhibitors such as PD-1, PD-L1, or CTLA-4 antibodies.
- Participation in other clinical studies within 14 days before this trial.
- Uncontrolled tumor-related pain.
- Known severe allergy to monoclonal antibodies.
- Allergy or intolerance to oxaliplatin or capecitabine ingredients.
- Pregnant or breastfeeding women.
- Other factors that might cause early study termination as judged by investigators.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 to 8 cycles of 3 weeks each
Participants receive serplulimab combined with CAPEOX and celecoxib as neoadjuvant treatment for locally advanced rectal cancer.
Visits every 3 weeks for treatment administration
Duration - 1 day
Participants undergo total mesorectal excision (TME) surgery following the treatment cycles.
1 visit (in-person) for surgery
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
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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