Colorectal cancer
Conditions
Interventions
Observation group:N/A
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age of 18-80 years old (at the time of signing the informed consent), male or female; 2. Colorectal cancer confirmed by postoperative pathology after radical surgery, and the postoperative pathological stage was stage II/III; Stage II patients should have high risk factors, including T4, poor histological differentiation, nerve or vascular invasion, preoperative intestinal obstruction or tumor perforation, positive or unknown resection margin, insufficient safe margin distance, and less than 12 lymph nodes examined. 3. Confirmed microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR); 4. No prior immunotherapy, chemotherapy, targeted therapy, or radiotherapy for colorectal cancer; 5. ECOG 0-1; 6. Expected survival time =12 weeks; 7. Had recovered from treatment-related toxicity before study entry; 8. Normal major organ function, i.e. meeting the following criteria: 1) Blood routine: Absolute Neutrophil Count (ANC) >=1.5×10^9/L, Platelet (PLT) >=70×10^9/L, Hemoglobin (HGB) >=90g/L; 2) Liver function: serum Total Bilirubin (TBIL) =28 g/L; Alkaline Phosphatase (ALP) =50 mL/mi (using the standard Cockcroft-Gault formula); 4) Coagulation: International Normalized Ratio (INR) <=1.5/PT<=1.5×ULN, aPTT<=1.5×ULN; If the subject is receiving anticoagulant therapy, as long as the PT and INR are within the prescribed range of anticoagulant drugs, it is ok. 5) Thyroid function: euthyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH was beyond the normal range, the subjects could be included if the total T3 (or FT3) and FT4 were within the normal range. 9. Subjects of childbearing potential had to be using an appropriate method of contraception during the study and for 120 days after the end of the study, had a negative serum pregnancy test within 7 days prior to study enrollment, and had to be non-lactating.
Exclusion criteria
Exclusion criteria: 1.Having active autoimmune diseases or having autoimmune diseases that may recur; 2.There are any subjects with severe and/or uncontrolled diseases. Subjects with autoimmune diseases or those with autoimmune diseases that may recur. 3.Poor control of diabetes (fasting blood glucose [FBG] > 10 mmol/L); 4.Those who underwent major surgical procedures, incisional biopsies or significant traumatic injuries within 28 days prior to the start of the treatment; or had long-standing unhealed wounds or fractures; 5.If there was a severe thromboembolic event (such as cerebrovascular accident including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, or pulmonary embolism within 6 months prior to the start of the treatment; 6.Those who have a history of substance abuse involving psychotropic drugs and are unable to quit, or those with mental disorders; 7.There was a serious lack of clinical data, including general conditions, laboratory examination results, imaging examination results and follow-up results, which were not enough to evaluate the efficacy and adverse reactions of patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The 3-year disease-free survival (DFS) rate; | — |
Countries
China
Contacts
Public ContactHan Zhengxiang
The Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed