Colon cancer
Conditions
Interventions
Experimental group:Camrelizumab + mFOLFOX6
Sponsors
The Affiliated Hospital of Guizhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Informed consent must be obtained from the subject voluntarily signed and dated in accordance with regulations and institutional guidelines prior to the implementation of any procedures related to the study protocol other than routine care content. 2. Age 18-75 years old. 3. There is definite histological evidence to confirm colorectal adenocarcinoma, and there are sufficient biopsy specimens for detection; Before treatment, immunohistochemistry was pMMR or genetic test was MSS. 4. ECOG performance status score of 0-1. 5. TNM staging of colon cancer by CT before surgery, confirmed to be T3, regardless of N; Rectal cancer was confirmed to be T3 by TNM staging by MRI before surgery, regardless of N. (TNM staging refers to the 8th edition of the AJCC/UICC TNM staging system for colorectal cancer) 6. Have not received systemic anti-tumor therapy for colorectal cancer in the past, including chemoradiotherapy, molecular targeted therapy, endocrine therapy, etc. 7. The following laboratory test values obtained before neoadjuvant therapy with appropriate organ function: Routine blood count: hemoglobin value>=90g/L, white blood cell count>=3×10^9/L, neutrophil count>=3.0×10^9/L, platelet count>=5×10^9/L Liver function: serum total bilirubin 50% Thyroid function: normal. 8. Willing and able to comply with study protocols and visit schedules.
Exclusion criteria
Exclusion criteria: 1. Before treatment, the immunohistochemical test was dMMR or the genetic test result was MSI-H; The primary colorectal tumor cannot be completely removed. 2. Whole-body CT, MRI, or PET-CT confirmed distant metastases (M1). 3. Patients with obstruction, active bleeding or perforation and need emergency surgery or stent placement. 4. Previous or concurrent presence of other active malignancies. 5. Existing serious infectious diseases or non-healing of infected wounds. 6. Active coronary artery disease, severe/unstable angina pectoris, or newly diagnosed angina pectoris or myocardial infarction within 12 months prior to study enrollment. 7. Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism, deep vein thrombosis within the past 6 months. 8. New York Heart Association (NYHA) Class II or above congestive heart failure. 9. Known presence of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related diseases. 10. Presence of active inflammatory bowel disease or other colorectal disease causing chronic diarrhea. 11. Presence of any prior therapy-induced CTCAE Grade 2 or above toxicity (anemia, alopecia) that has not resolved 12. Prior receipt of any investigational agent. 13. History of blood transfusion and organ transplantation in the past. 14. Pregnant or lactating women. 15. Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia. 16. Unstable or any medical condition that would affect patient safety and their compliance with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative pathological remission rate(MPR+PR); | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year Disease Free Survival;3-year Overall Survival;Pathologic Complete Response;Tumor downstaging (including tumor diameter, tumor stage, lymph node status, TRG grade);Perioperative complications; | — |
Countries
China
Contacts
Public ContactZhen Yunhuan
The Affiliated Hospital of Guizhou Medical University
Outcome results
None listed