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Table 1 Inclusion and exclusion criteria

From: Short-course radiotherapy combined with CAPOX and Toripalimab for the total neoadjuvant therapy of locally advanced rectal cancer: a randomized, prospective, multicentre, double-arm, phase II trial (TORCH)

Inclusion criteria

Exclusion criteria

1. Pathological confirmed adenocarcinoma

2. Clinical stage T3-4 and/or N + 

3. The distance from anal verge ≤ 12 cm

4. Without distance metastases

5. Age 18–70 years old, female and male

6. KPS >  = 70

7. 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

8. With good compliance and signed the consent form

1. Pregnancy or breast-feeding women

2. Known history of other malignancies within 5 years

3. Known history of previous anti-tumor treatment, including radiotherapy, chemotherapy, immune checkpoint inhibitors, T cell-related therapy, etc

4. Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy)

5. Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction

6. Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment

7. Uncontrolled infection which needs systemic therapy

8. Active autoimmune disease or immunodeficiencies, known history of organ transplantation or systematic use of immunosuppressive agents

9. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1 to 2 antibody positive), active syphilis infection, active pulmonary tuberculosis infection

10. 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)

11. Allergic to any component of the therapy