Rectal cancer
Conditions
Interventions
Case series:Sintilimab+Hypofractionated radiotherapy
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with rectal adenocarcinoma confirmed by histopathology, excluding anal squamous cell carcinoma; 2. The patients diagnosed as dMMR by immunohistochemistry or MSI-H (PCR or NGS) by gene detection whatever it's Lynch syndrome or not; 3. Patients who have not received any anti-tumor treatment for rectal cancer in the past. In the case of Lynch syndrome, no anti-tumor treatment has been done for this diagnosis of colorectal cancer; 4. The local clinical staging of rectum based on high-resolution Pelvic MRI is: the distance between the lower edge of the tumor and the anal margin is less than 15 cm, the clinical stage is T2 or above, N0-2, with or without positive lateral lymph nodes, regardless of MRF or EMVI status. No signs of distant metastasis (not including lateral lymph nodes) were found in chest and abdomen enhanced CT; 5. Patients aged >= 18 years old; 6. Patients with ECoG physical status score of 0 – 1; 7. Patients with adequate organ and bone marrow function: (1) Blood routine examination: hemoglobin value >= 90g / L, neutrophil count >= 1.5 x 10^9 / L, platelet count >= 75 x 10^9 / L; (2) Liver function: serum total bilirubin = 50ml / min; (4) Coagulation function: INR, APTT and PT were all = 28g / L; (6) Thyrotropin (TSH) and free thyroxine (FT4) were within ± 10% of normal values; (7) There was no obvious abnormality in ECG. 8. Patients who did not receive blood transfusion, blood products or blood cell growth factors such as granulocyte colony-stimulating factor within 2 weeks; 9. Patients who signed informed consent prior to the start of the study's specific screening procedures; 10. Patients who are expected to survive for more than 3 months.
Exclusion criteria
Exclusion criteria: 1. Patients with allergic diseases, severe drug allergy history, and known allergy to macromolecular protein preparations or cindili; 2. Patients with a disease-free survival of less than 5 years with a history of other malignant tumors (except cured basal cell carcinoma of skin, cured carcinoma in situ of cervix, and digestive tract tumor confirmed to be cured by endoscopic mucosal resection); 3. Patients with any active autoimmune disease or history of autoimmune diseases (including but not limited to interstitial pneumonia, uveitis, enteritis, hepatitis (HBV DNA >= 103copies / ml after regular antiviral treatment), nephritis, hyperthyroidism and hypothyroidism); 4. Patients who are using immunosuppressive agents or hormone therapy (systemic or local use) to achieve the purpose of immunosuppression, and continue to use them within 2 weeks before enrollment; 5. Patients with severe infection (such as intravenous use of antibiotics, antifungal or antiviral drugs, etc.); 6. Patients with congenital or acquired immune deficiency (such as HIV infection), or active hepatitis (HBV DNA >= 103copies / ml after regular antiviral treatment); 7. Any of the following complications: (1) Massive gastrointestinal bleeding, perforation or obstruction (including paralytic ileus); (2) Symptomatic heart disease (including unstable angina, myocardial infarction and heart failure); (3) Uncontrolled diabetes and hypertension; (4) Uncontrollable diarrhea (although well treated, it still interferes with daily activities). 8. Patients with bleeding tendency or undergoing thrombolytic or anticoagulant therapy; 9. Women during pregnancy or lactation, as well as men and women who are not willing to take contraceptive measures; 10. Patients with mental disorders that interfere with research compliance; 11. Other situations in which the researcher considers it inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy;Quality of life; | — |
Countries
China
Contacts
Public ContactMeng Qiu
West China Hospital of Sichuan University
Outcome results
None listed