Actively Recruiting
Neoadjuvant Chemotherapy Plus Sequential Immune Checkpoint Inhibitor (ICI) Therapy in Locally Advanced Colon Cancer
Led by Ruijin Hospital · Updated on 2025-09-24
56
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn the effect of neoadjuvant chemotherapy plus sequential immune checkpoint inhibitor (ICI) therapy in locally advanced colon cancer. The main questions it aims to answer are: * Does this neoadjuvant chemotherapy increase the pathologic complete response (pCR) of locally advanced colon cancer? * Does this neoadjuvant chemotherapy improve the long-term survival of locally advanced colon cancer? Participants will receive: * a pre-operative CAPEOX (capecitabine oral + oxaliplatin i.v.)regimen. * a sequential CAPEOX plus Serplulimab regimen. * a standard complete mesocolic excision (CME) operation.
CONDITIONS
Official Title
Neoadjuvant Chemotherapy Plus Sequential Immune Checkpoint Inhibitor (ICI) Therapy in Locally Advanced Colon Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who volunteer and fully understand the study and sign the informed consent form
- Male or female aged 18 to 75 years at the time of consent
- Histopathologically confirmed primary colon adenocarcinoma
- MSS/RAS mutation patients with clinical stages T3N1-2 and T4N0-2
- ECOG performance status score of 0 or 1
- At least one measurable lesion meeting RECIST 1.1 criteria
- Provide tumor tissue suitable for MSI/MMR testing
- Expected survival of at least 3 months
- Negative hepatitis B surface antigen and core antibody or controlled hepatitis B virus DNA levels
- Negative hepatitis C antibody or RNA with liver enzymes within specified limits
- Adequate organ and bone marrow function confirmed by recent laboratory tests
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and for 3 months after treatment
- Male participants with partners of childbearing potential must be surgically sterilized or agree to use effective contraception during and for 3 months after treatment
You will not qualify if you...
- Recurrent colon cancer or prior treatments including radiation, surgery, chemotherapy, immunotherapy, or targeted therapy
- Severe infection requiring intravenous antibiotics or unexplained fever above 38.5°C within 4 weeks
- Uncontrolled hypertension (systolic ≥140 mmHg or diastolic ≥90 mmHg)
- Significant bleeding symptoms or need for long-term anticoagulant or high-dose antiplatelet therapy
- Active heart disease including recent myocardial infarction or severe angina within 6 months
- Other malignancies within past 5 years except certain skin or cervical cancers
- Active or uncontrolled serious infections
- Known HIV infection
- Significant liver disease including active hepatitis B or C infections
- Severe cardiac insufficiency or left ventricular ejection fraction below 50%
- Active pulmonary tuberculosis or severe lung diseases
- Known or suspected autoimmune diseases except well-controlled certain conditions
- Recent live vaccine use within 28 days
- Need for systemic corticosteroids or immunosuppressive drugs within 14 days or during study
- Active infections requiring treatment or recent positive COVID-19 test
- Major surgery within 28 days before randomization
- Previous treatment with immune checkpoint inhibitors
- Participation in other clinical studies within 14 days before this study
- Uncontrolled tumor-related pain
- Severe allergies to monoclonal antibodies or study drug components
- Pregnancy or breastfeeding
- History of substance abuse or alcoholism
- Other medical conditions judged by investigators to interfere with study or pose risk
- Any other factors that may cause premature study termination by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
T
Tao Zhang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here