rectal cancer
Conditions
Interventions
1:A short-course radiotherapy SCRT, 5 Gy x 5
Sponsors
Tongji Hospital of Tongji University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Pathology confirmed rectal cancer with pMMR or MSS. 2. Histologically confirmed adenocarcinoma of rectum (T3-4or N+) 3. the inferior margin of the tumor is at a distance of 12 cm or less from the AV before CRT 4. Non-metastatic, 5. Age 18-70 years old, female and male; 6. Patients with the ECOG performance status of 0 or 1 at the time of enrollment 7. No previous chemotherapy, radiotherapy, immunotherapy or other anti-tumor treatment; 8. Patients must have acceptable organ and marrow function as defined below: Absolute neutrophil count (ANC) >1,500/uL Hg > 8.0 g/dL; if blood transfusion is performed for achieving adequate hemoglobin level, the level should stay above goal for at least 1 week after transfusion Platelets >100,000/uL Total bilirubin 50 by Cockcroft-Gault. T3 and T4 normal. 9.Patients who personally provided written consent for participation in the study 10.With good compliance and no serious comorbidity 11.Women of childbearing age must have taken reliable contraceptive measures or have a pregnancy test (serum or urine) within 7 days prior to enrollment and the results are negative; 12. Women of childbearing age should agree to use contraception (e.g. IUD, birth control pills or condoms) for the duration of the study and for 120 days after the end of the study; Negative serum or urine pregnancy tests within 7 days prior to study enrollment.
Exclusion criteria
Exclusion criteria: 1. The patient has previously received immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.) 2. Allergic to any component of chemotherapy or immunotherapy; 3. With Bleeding (rectal cancer bleeding is allowed to join) 4. Pregnant women or breast-feeding women; 5. History of other uncured malignancies within 5 years; 6. History of epilepsy and dysphrenia; 7. With uncontrolled cardiovascular disease: active coronary heart disease; grade III-IV cardiac insufficiency according to the NYHA criteria; and myocardial infarction within 1 year; 8. Usage of corticosteroids (prednison dose of > 10 mg/day) or other immunosuppressors for systemic treatment within the first 14 days of research; 9. Have received surgery within 4 weeks before the enrollment; 10. With active infection or fever with unknown cause (tumor-induced fever judged could be enrolled); 11. History of active autoimmune disease, interstitial lung disease 12. With congenital or acquired immunodeficiency (such as those with HIV infection), 13. Active tuberculosis 14. active hepatitis B or hepatitis C; 15. Patients with significant unstable mental diseases or other medical diseases that may interfere with the safety of the subjects, obtaining informed consent, or compliance with the procedures for the clinical study 16. With other factors that would force to terminate the clinical trial ahead of time, such as the development of other severe comorbidity that required combined treatment, and family or social factors affecting the safety of patients or experimental data collection, as judged by the researchers. 17. Presence of medical history, disease, treatment, or abnormal laboratory results that could interfere with the test results, prevent the subject from participating throughout the study, or that, in the opinion of the investigator, are not in the subject's best interest.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete remission;clinical complete remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| Neoadjuvant rectal score (NAR score);Incidence of Treatment-Emergent Adverse Events; | — |
Countries
China
Contacts
Public ContactZhiqian Hu
Tongji Hospital of Tongji University
Outcome results
None listed