Adebrelimab Injection (PD-L1) Combined With Short Course Radiotherapy and Chemotherapy for Neoadjuvant Therapy of Locally Advanced Rectal Cancer

Exclusion Criteria

• •1. Patients diagnosed with other malignant tumors that have not been cured within 5 years before the first administration (excluding skin basal cell carcinoma, squamous cell carcinoma, and/or carcinoma in situ that has undergone radical resection);
• •2. Late stage rectal cancer patients with distant metastasis;
• •3. Currently participating in interventional clinical research treatment, or having received other research drugs or used research instruments for treatment within 4 weeks before the first administration;
• •4. Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs that stimulate or synergistically inhibit T cell receptors (such as CTLA-4, OX-40, CD137);
• •5. Have received systemic treatment of traditional Chinese patent medicines and simple preparations with anti-tumor indications or drugs with immunomodulatory effect within 2 weeks before the first administration;
• •6. Within 2 years prior to the first administration, there has been an active autoimmune disease requiring systemic treatment (such as the use of disease relieving drugs, corticosteroids, or immunosuppressants). Alternative therapies (such as thyroid hormone, insulin, or physiological glucocorticoids used for adrenal or pituitary insufficiency) are not considered systemic treatments;
• •7. Within 7 days prior to the first administration of the study, the individual was receiving systemic corticosteroid therapy (excluding topical corticosteroids via nasal spray, inhalation, or other routes) or any other form of immunosuppressive therapy;Note: Physiological doses of glucocorticoids (≤ 10 mg/day of prednisone or equivalent) are allowed to be used;
• •8. Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
• •9. Those who are known to be allergic to the active ingredients or excipients of the investigational drug Adabelimab and combination chemotherapy drugs;
• •10. Prior to commencing treatment, the individual has not fully recovered from any toxicity and/or complications caused by any intervention measures (i.e., ≤ grade 1 or baseline, excluding fatigue or hair loss);
• •11. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive);
• •12. Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected is greater than the upper limit of normal value in the laboratory of the research center);Note: hepatitis B patients who meet the following criteria can also be included in the group:
• •* Prior to the first administration, if the HBV viral load is less than 1000 copies/ml (200 IU/ml), subjects should receive anti HBV treatment throughout the entire study chemotherapy period to avoid viral reactivation
• •* For subjects with anti HBc (+), HBsAg (-), anti HBs (-), and HBV viral load (-), prophylactic anti HBV treatment is not necessary, but close monitoring of viral reactivation is necessary
• •13. Active HCV infected subjects (HCV antibody positive and HCV-RNA level above the detection limit);
• •14. Administer a live vaccine within 30 days prior to the first dose (Day 1 of the first cycle);Note: It is allowed to receive inactivated vaccine for seasonal influenza within 30 days before the first administration; However, intranasal administration of attenuated live influenza vaccine is not allowed.
• •15. Pregnant or lactating women;
• •16. There are any serious or uncontrollable systemic diseases, such as:
• •* Resting electrocardiogram shows significant and difficult to control abnormalities in rhythm, conduction, or morphology, such as complete left bundle branch block, grade II or higher heart block, ventricular arrhythmia, or atrial fibrillation;
• •* Unstable angina pectoris, congestive heart failure, chronic heart failure classified as NYHA ≥ 2;
• •* Myocardial infarction occurred within 6 months prior to enrollment;
• •* Poor blood pressure control (systolic blood pressure\>140 mmHg, diastolic blood pressure\>90 mmHg);
• •* A history of non infectious pneumonia requiring corticosteroid treatment within the year prior to the first administration, or current clinical active interstitial lung disease;
• •* Active pulmonary tuberculosis;
• •* There are active or uncontrolled infections that require systemic treatment;
• •* There is clinical active diverticulitis, abdominal abscess, and gastrointestinal obstruction;
• •* Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;
• •* Poor control of diabetes (FBG\>10mmol/L);
• •* Urine routine shows urinary protein ≥++and confirms 24-hour urinary protein quantification\>1.0 g;
• •* Patients with mental disorders who are unable to cooperate with treatment;
• •17. Medical history or disease evidence, abnormal treatment or laboratory test values that may interfere with the trial results, hinder the full participation of the subjects in the study, or other situations that the researchers believe are not suitable for inclusion. The researchers believe that there are other potential risks and they are not suitable to participate in this study.