Rectal adenocarcinoma
Conditions
Interventions
Experimental group:PD-1 monoclonal antibody combined with chemoradiotherapy combined with Capox therapy
Sponsors
He'nan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Pathological diagnosis of rectal adenocarcinoma; 2. Baseline clinical staging was T3-4 and/or N+M0, and neoadjuvant chemoradiotherapy was planned; 3. Need for tumor retreat; 4. Aged 18-75 years, no gender limit; 5. ECOG score 0-1; 6. Detection of MSS, KRAS, NRAS and BRAF gene status; 7. Ability to adhere to the study protocol during the study period; 8. For female patients who are not menopausal or have not been surgically sterilized: consent to abstinence from sex or use of effective contraceptive methods during treatment and for at least 7 months after the last dose in the study treatment; 9. A voluntary informed consent to participate in the experimental treatment and an informed consent to participate in the observational study.
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing patients; 2. For patients with a history of uncontrolled epilepsy, central nervous system disease or mental disorder, the clinical severity of which, as determined by the researcher, may prevent the signing of informed consent or affect the patient's compliance with oral medication; 3. Clinically severe (i.e. active) heart disease, such as symptomatic coronary heart disease, NYHA Class II or worse congestive heart failure, or severe arrhythmias requiring medical intervention, or a history of myocardial infarction within the last 12 months; 4. Patients who need immunosuppressive therapy for organ transplantation; 5. Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases; 6. Baseline blood routine and biochemical indexes of the observed patients did not meet the following standards: hemoglobin >=90g/L; Absolute count of neutrophils (ANC) >=1.5x10^9/L; Platelet >=100x10^9/L; ALT, AST=30g/L; 7. Autoimmune diseases or other diseases requiring systemic treatment with corticosteroids or immunosuppressive drugs (physical corticosteroid replacement therapy for adrenal or pituitary insufficiency is allowed); 8. Known allergic history of drug components of the program; A history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation; 9. A serious concomitant disease or other co-morbid condition that would interfere with planned treatment, or any other condition in which the investigator considers the patient unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;3-year disease-free survival;3-year overall survival;Security;Quality of life score; | — |
Countries
China
Contacts
Public ContactGuo Leiming
He'nan Cancer Hospital
Outcome results
None listed