Short-course Radiotherapy Based TNT Combined With PD-1 Inhibitor for Locally Advanced Rectal Cancer

Inclusion criteria

• Pathological confrmed adenocarcinoma
• Clinical stage T3-4 and/or N+
• The distance from anal verge ≤12 cm
• Without distance metastases
• Age 18-70 years old, female and male
• KPS > =70
• Baseline blood and biochemical indicators meet the following criteria: neutrophils≥1.5×10^9/L, Hb≥90 g/L, PLT≥100×10^9/L, ALT/AST≤2.5 ULN, Cr≤1 ULN
• With good compliance and signed the consent form

Exclusion criteria

• Pregnancy or breast-feeding women
• Known history of other malignancies within 5 years
• Known history of previous anti-tumor treatment, including radiotherapy, chemotherapy, immune checkpoint inhibitors, T cell-related therapy, etc
• Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy)
• Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction
• Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment
• Uncontrolled infection which needs systemic therapy
• Active autoimmune disease or immunodefciencies, known history of organ transplantation or systematic use of immunosuppressive agents
• Known history of human immunodefciency virus (HIV) infection (i.e., HIV 1 to 2 antibody positive), active syphilis infection, active pulmonary tuberculosis infection
• Active Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (i.e., HBsAg positive or HBV DNA positive, HCV RNA positive if anti-HCV antibody testing positive)
• Allergic to any component of the therapy