Gastrointestinal diseases
Conditions
Interventions
experimental group:Sintilimab combined with chemoradiotherapy
Sponsors
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before implementing any trial-related procedures; 2. No gender limit, aged 18-85 years; 3. Patients diagnosed with rectal adenocarcinoma by histopathological examination of primary tumor biopsy; 4. Patients who are judged to be operable by imaging and colonoscopy and need neoadjuvant therapy (cT stage >=T3 or cN stage N1+, M0 or EMVI (+) or MRF (+) or suspected lateral lymph node metastasis (>5mm)); 5. It is judged by imaging and colonoscopy that the main body of the patient's tumor is located =1.5x10^9/L without the use of granulocyte colony-stimulating factor in the past 14 days; (2) Platelets >=100x10^9/L without blood transfusion in the past 14 days; (3) Hemoglobin>9g/dL without blood transfusion or erythropoietin in the past 14 days; (4) Total bilirubin =60 ml/min; (7) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; (8) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, patients with total T3 (or FT3) and FT4 within the normal range can also be enrolled; (9) Myocardial enzyme spectrum is within the normal range (if the investigators comprehensively judge that the simple laboratory abnormality does not have clinical significance, it is also allowed to be included in the group); 10. For female patients of childbearing age, a negative urine or serum pregnancy test should be performed within 3 days prior to receiving the first dose of study drug (Day 1 of Cycle 1). If a urine pregnancy test result cannot be confirmed negative, a blood pregnancy test is required. Women of non-reproductive age are defined as having been postmenopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy; 11. If there is a risk of conception, all patients (whether male or female) are required to use contraceptive measures with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last dose of the study drug (or 180 days after the last chemotherapy drug dose).
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed with other malignant tumors within 5 years before the first administration and not cured (excluding basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection); 2. Patients with advanced rectal cancer with distant metastasis; 3. Currently participating in interventional clinical research treatment, or have received other investigational drugs or used investigational device treatment within 4 weeks before the first dose; 4. Active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, glucocorticoids or immunosuppressants) has occurred within 2 years before the first dose. Replacement therapy (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, etc.) is not considered systemic therapy; 5. Are receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first dose of the study (Note: Physiological doses of glucocorticoids (<=10 mg/day prednisone or equivalent) are allowed); 6. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 7. Those who are known to be allergic to the study drug sintilimab and the active ingredients or excipients of combined chemotherapy drugs; 8. Has not recovered sufficiently from toxicity and/or complications from any intervention (ie, <= Grade 1 or reached baseline, excluding fatigue or alopecia) prior to initiating treatment; 9. Known history of human immunodeficiency virus (HIV) infection (ie HIV 1/2 antibody positive); 10. Untreated active hepatitis B (defined as HBsAg positive and the detection of HBV-DNA copy number greater than the upper limit of the normal value of the laboratory department of the research center), hepatitis B patients who meet the following criteria can also be enrolled: (1) HBV viral load <1000 copies/ml (200 IU/ml) before the first dose, patients should receive anti-HBV therapy during the entire study chemotherapy drug treatment period to avoid viral reactivation; (2) For patients with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), prophylactic anti-HBV treatment is not required, but viral reactivation needs to be closely monitored; 13. Active HCV infected patients (HCV antibody positive and HCV-RNA level higher than the detection limit); 14. Received live vaccine within 30 days prior to first dose (cycle 1, day 1) (Note: Injected inactivated virus vaccine against seasonal influenza within 30 days prior to the first dose is permitted; however, intranasal live attenuated influenza vaccine is not permitted.); 15. Lactating patients; 16. Presence of any serious or uncontrollable systemic disease such as: (1) There are significant abnormalities in the rhythm, conduction or morphology of the resting ECG, and the symptoms are severe and difficult to control, such as complete left bundle branch block, second-degree heart block, ventricular arrhythmia or atrial fibrillation; (2) Unstable angina pectoris, congestive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic Complete Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Partial Response Rate;Complete Remission Rate;Objective Response Rate;Main Pathological Remission Rate;R0 Resection Rate; | — |
Countries
China
Contacts
Public ContactJing Changqing
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Outcome results
None listed