rectal cancer
Conditions
Interventions
experimental group:camrelizumab+CAPOX
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old, both male and female; 2. Patients with T3-4N0M0 or T1-4N+M0 rectal cancer confirmed by histology (who have not received anti-tumor treatment in the past); 3.ECOG01; 4. Tumor distance from anal margin = 10cm 5. Expected survival time = 12 weeks; 6. If the main organs function normally, they meet the following standards: (1) Blood routine examination: a.HB=90g/L; b.ANC=1.5 × 10^9/L; c.PLT =80 × 10^9/L; (2) Biochemical examination: a.ALB=30g/L; b. ALT and AST = 2.5ULN; If there is liver metastasis, ALT and AST = 5ULN; c.TBIL=1.5ULN; d. Plasma Cr = 1.5ULN or creatinine clearance rate (CCr) = 60ml/min; 7. Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) = lower limit of normal value (50%); 8. Women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives, or condoms) during the study period and within 6 months after the end of the study; Within 7 days prior to enrollment in the study, the serum or urine pregnancy test was negative and must be a non lactating patient; Men should agree to patients who must use contraception during the study period and within 6 months after the end of the study period; 9. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Does not meet the above selection criteria; 2. Individuals with allergies or metabolic disorders to capecitabine or platinum based drugs; 3. The patient has any active autoimmune disease or a history of autoimmune disease (For example, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; asthma that has completely relieved in childhood and does not require any intervention in adulthood can be included; asthma that requires medical intervention with bronchodilators cannot be included); 4. The patient is currently using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive effects (dosage>10mg/day of prednisone or other therapeutic hormones) and continues to use them within 2 weeks before enrollment; 5. Patients with any severe and/or uncontrollable diseases, including those with poor blood pressure control (systolic blood pressure = 150mm Hg or diastolic blood pressure = 100 mmHg); Suffering from grade I or above myocardial ischemia or infarction, arrhythmia (including QT interval = 480ms), and grade I cardiac dysfunction; 6. Active or uncontrollable serious infections; 7. Liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA = 104 copies/ml or 2000IU/ml) or hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the detection limit of the analytical method); 8. Urinary routine examination indicates that urine protein is =++, and it is confirmed that 24-hour urine protein quantification is greater than 1.0g; 9. Pregnant or lactating women; Patients with other malignant tumors within 10.5 years (excluding cured skin basal cell carcinoma and cervical carcinoma in situ); 11. Patients who have a history of abuse of psychotropic substances and are unable to quit or have mental disorders; 12. Patients who have participated in clinical trials of other drugs within four weeks; 13. According to the judgment of the investigator, there are patients with concomitant diseases that seriously endanger the safety of patient safety or affect the completion of the study; 14. Researchers believe that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;R0 resection rate;safety; | — |
Countries
China
Contacts
Public ContactWangGuixian,Songmin
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed