Fruquintinib Plus PD-1 Antibody in pMMR / MSS Locally Advanced Rectal Cancer (LARC) With High Immune Score

Exclusion Criteria

• •1. Any active autoimmune disease or history of autoimmune disease;
• •2. Immunosuppressants, systemic or absorbable local hormones are being used to achieve the purpose of immunosuppression (dose \> 10mg / day, prednisone or other effective hormones) and continue to be used within 2 weeks before enrollment;
• •3. History of severe allergic reaction to monoclonal antibody;
• •4. Subjects with untreated active brain metastasis or meningeal metastasis with clinical symptoms;
• •5. Suffering from hypertension and can not be well controlled by antihypertensive drugs (systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg);
• •6. Have previously received other PD-1 antibody therapy or other immunotherapy against PD-1 / PD-L1, or have previously received anti angiogenesis drugs;
• •7. There are cardiac clinical symptoms or diseases that are not well controlled, such as: (1) heart failure above NYHA grade 2 (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
• •8. Known hereditary or acquired bleeding and thrombotic tendency (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.) or undergoing thrombolytic or anticoagulant therapy;
• •9. Urine routine examination indicates that urinary protein is ≥ + +, or confirmed 24-hour urinary protein is ≥ 1.0g;
• •10. Significant clinical bleeding symptoms or definite bleeding tendency occurred within 3 months before enrollment, such as gastrointestinal bleeding, active bleeding, baseline fecal occult blood + + or above, or vasculitis;
• •11. Arteriovenous thrombosis events occurred within 6 months before enrollment, such as cerebrovascular accidents (including transient ischemic attack, intracerebral hemorrhage and cerebral infarction), deep venous thrombosis and pulmonary embolism;
• •12. Subjects with active infection;
• •13. Congenital or acquired immune deficiency (such as HIV infection) or active hepatitis (hepatitis B: HBsAg positive and HBV DNA \> 104 copy number /ml; Hepatitis C: HCV antibody positive);
• •14. Those who participated in clinical trials of other drugs within 3 months before enrollment;
• •15. There was evidence of distant metastasis before operation;
• •16. History of pelvic or abdominal radiotherapy;
• •17. Any other malignant disease within the preceding 5 years with the exception of cured skin basal cell carcinoma, cervical carcinoma in situ and ovarian cancer;
• •18. Live vaccines were administered less than 4 weeks before the study or possibly during the study period;
• •19. Known or suspected allergy to the study drug or to any drug given in connection with this test;
• •20. In the judgment of the researcher, the subject has other circumstances that may affect the results of the study or cause the study to be forced to stop halfway.