Rectal cancer
Conditions
Interventions
TRIAL GROUP:Ultrasonic microbubble cavitation sequential CAPOX protocol combined with Sindilizumab injection
Sponsors
The First Affiliated Hospital Of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Colorectal cancer with histologically confirmed adenocarcinoma and radiographic evaluation of T3-4N0M0 or T1-4N+M0; 2. Patients ranged in age from 18 to 75 years; 3. The Eastern Cancer Cooperative Group (ECOG) scored 0 or 1; 4. The tumor is less than 10cm from the anus. 5. All enrolled patients need to be confirmed as MSS or pMMR patients by tumor pathologic examination (molecular biological method or immunohistochemical method). 6. Bone marrow, liver and renal function: absolute neutrophil count (ANC) =1.5×109/L, hemoglobin =85g/L, platelets =80×109/L, serum creatinine =176.8µmol/L, AST and ALT=5 times the upper limit of normal (ULN); Total bilirubin =51µmol/L, PT <4 seconds longer than normal or normal (INR<1.7), albumin greater than 30g/dl. 7. Subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up
Exclusion criteria
Exclusion criteria: 1. Does not meet the above inclusion criteria. 2. Complicated intestinal obstruction and heavy bleeding. 3. People with allergies or metabolic disorders to perfluorobutane microspheres, capecitabine or platinum-based drugs for injection. 4. The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, inflammatory bowel disease, hypophysitis, vasculitis, nephritis, hyperthyroidism; The patient had vitiligo; Those with complete remission of asthma in childhood can be included without any intervention in adulthood; Patients with asthma requiring medical intervention with bronchodilators are not included); 5. Patients who are taking immunosuppressants or systemic hormone therapy for immunosuppressive purposes (dose >10mg/ day prednisone or other therapeutic hormones) and continue to use within 2 weeks before enrollment; 6. Previously received anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibody therapy, or any other antibody or drug that specifically targets T cell co-stimulation or immune checkpoint pathway, or other immune drug therapy; 7. Patients with any severe and/or uncontrolled disease, including: patients with unsatisfactory blood pressure control (systolic =150mmHg or diastolic =100 mmHg); Suffering from grade I or above myocardial ischemia or myocardial infarction, arrhythmias (including QT interval =480ms) and grade I cardiac insufficiency; 8. Active or uncontrolled severe infection; 9. Liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA=104 copy number /ml or 2000IU/ml), or hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower detection limit of analytical methods); 10. Urine routine indicated urine protein =++, and confirmed 24-hour urine protein quantity > 1.0g; 11. Pregnant or lactating women; Patients with other malignancies within 12.5 years; 13. Patients who have a history of psychotropic drug abuse and cannot quit or have mental disorders; 14. Patients who have participated in clinical trials of other drugs within four weeks; 15. Patients with concomitant diseases that, in the judgment of the investigator, seriously endanger the patient's safety or interfere with the patient's completion of the study; 16. Patients with incomplete basic information. 17. Those deemed unsuitable for inclusion by the researchers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological examination of tumors;The length of the tumor;Distance from the base of the tumor to the anal margin; | — |
Countries
China
Contacts
Public ContactZhenqiang Sun
The First Affiliated Hospital Of Zhengzhou University
Outcome results
None listed