Short-course Radiotherapy Followed by Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer

Exclusion Criteria

• •Previous treatment with anti-PD-1/L1 and anti-CTLA-4 or other immune experimental drugs.
• •Severe autoimmune disease: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (e.g. Wegener's granulomatosis)
• •Symptomatic interstitial lung disease or active infectious/non-infectious pneumonia.
• •At risk for bowel perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer or other known risk factors for bowel perforation.
• •history of other malignancies, excluding curable non-melanotic skin cancer and cervix carcinoma in situ；
• •Active infection, heart failure, heart attack within 6 months, unstable angina or unstable arrhythmia.
• •Any condition investigator considered may interfere with the results or place the patient at increased risk of treatment complications, or other uncontrollable disease.
• •Pregnancy or breast feeding
• •Immunodeficiency disorders including human immunodeficiency virus (HIV), or history of organ transplantation, allogeneic stem cell transplantation
• •Active hepatitis B virus (HBV) hepatitis (HBV-DNA ≥ 2000 U/mL), hepatitis C virus (HCV) hepatitis, active tuberculosis infection.
• •Oncology vaccination history or any vaccination within 4 weeks prior to the start of treatment.(Note: influenza vaccines are mostly inactivated and therefore allowed, intranasal preparations are usually live attenuated vaccines and therefore not allowed)
• •Concomitant other immune agents, chemotherapeutic agents, other drugs in clinical studies, and long term cortisol application