Chemoradiotherapy Combined With or Without PD-1 Blockade in Anal Canal Squamous Carcinoma Patients

Exclusion Criteria

• •1. Diagnosed as stage I-II and well differentiated squamous cell carcinoma,
• •2. Distant metastasis,
• •3. Received radiation therapy in abdominal or pelvic regions,
• •4. Pregnant, lactating woman patient or fertile but lacks adequate contraceptives,
• •5. Arrhythmia need anti-arrhythmia treatment (except β-blocking agent or Digoxin), symptomatic coronary heart disease or myocardial ischemia (myocardial infarction within 6 months) or congestive heart-failure (CHF) \> New York Heart Association grade II,
• •6. Severe hypertension not well controlled by drugs,
• •7. Active phase of chronic hepatitis B or hepatitis C (high copies of virus DNA),
• •8. Patients with active tuberculosis (TB) are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before screening,
• •9. Other active clinical severe infection (NCI-CTCAE (version 4.0) ),
• •10. Dyscrasia, organ dysfunction,
• •11. Known or suspicious allergy to any research-related drugs,
• •12. Epilepsy needs treatments (Steroid or anti-epilepsy therapy),
• •13. Other malignant tumor history within 5 years,
• •14. Drug abuse and medical, psychological, or social factors that may interfere with patients' participation in the study or affect the evaluation of the study,
• •15. Patients have any active autoimmune diseases or a history of autoimmune diseases (including but not restricted: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism and decreased thyroid function; patients with vitiligo or with complete remission of asthma in childhood and without any intervention in adulthood may be included; patients with asthma requiring bronchodilators intervention are not included,
• •16. Any anti-infection vaccine 4 weeks before inclusion,
• •17. Long-term exposure to immune-suppressor, combination of systemic or topical use of corticosteroids (dose\>10mg/day prednisolone or equivalent hormone),
• •18. Any unstable state might endanger the patients' safety and compliance,
• •19. Refuses to sign informed consent.