Sintilimab in Combination With Chidamide in Refractory and Relapsed ENKTCL

Who cannot join

• 1. Invasive natural killer cell leukemia; 2. Hemophagocytic syndrome; 3. Primary central nervous system lymphoma or secondary central nervous system involvement; 4. Received organ transplantation in the past; 5. Patients who received allogeneic hematopoietic stem cell transplantation within three years before the drug was given (patients who received allogeneic hematopoietic stem cell transplantation more than three years before the drug was given and who currently have no graft-versus-host response can be enrolled); 6. Participating in other clinical studies or planning to start this study is less than 4 weeks from the end of the previous clinical study; 7. Autologous hematopoietic stem cell transplantation was performed within 90 days before the start of the study; 8. The drug was treated with histone deacetylase inhibitors within one year before administration; 9. Patients with active autoimmune diseases requiring systematic treatment in the past two years (hormone replacement therapy is not considered systematic treatment, such as type I diabetes mellitus, hypothyroidism requiring only thyroxine replacement therapy, adrenocortical dysfunction or pituitary dysfunction requiring only physiological doses of glucocorticoid replacement therapy); Patients with autoimmune diseases who do not require systematic treatment within two years can be enrolled; 10. Begin the study on subjects requiring systemic glucocorticoid therapy or other immunosuppressive therapy for a given condition within 14 days before treatment [allowing subjects to use local, ocular, intra-articular, intranasal and inhaled glucocorticoid therapy (with very low systemic absorption); and allowing short-term (< 7 days) glucocorticoid prophylaxis (e.g., contrast agent overdose) Sensitivity) or for the treatment of non-autoimmune diseases (e.g. delayed hypersensitivity caused by contact allergens); 11. In the past five years, patients with other malignant tumors have undergone radical treatment, except for basal cell carcinoma of skin, squamous cell carcinoma of skin, carcinoma in situ of breast and carcinoma in situ of cervix.
• 12. Begin the study and receive systemic antineoplastic therapy within 28 days before treatment, including chemotherapy, immunotherapy, biotherapy (cancer vaccine, cytokines, or growth factors that control cancer), etc.; 13. The study began with major surgery within 28 days before treatment or radiotherapy within 90 days before treatment; 14. Start the study and receive Chinese herbal medicine or Chinese patent medicine treatment within 7 days before treatment; 15. Begin research on live vaccination (except influenza attenuated vaccine) within 28 days before treatment; 16. History of human immunodeficiency virus (HIV) infection and/or patients with acquired immunodeficiency syndrome are known; 17. Patients with active hepatitis B or active hepatitis C. Patients who are positive for hepatitis B Surface Antigen (HBsAg) or hepatitis C Virus (HCV) antibodies at screening stage must pass further detection of hepatitis B Virus (HBV) DNA titer (no more than 2500 copies/mL or 500 IU/mL) and HCV RNA (no more than the lower limit of the detection method) in the row. In addition to active hepatitis B or hepatitis C infections requiring treatment, group trials can be conducted. Hepatitis B carriers, stable hepatitis B (DNA titer should not be higher than 2500 copies/mL or 500 IU/mL) after drug treatment, and cured hepatitis C patients can be enrolled in the group; 18. Patients with active pulmonary tuberculosis; 19. Start studying any active infections requiring systemic anti-infective treatment within 14 days of treatment.
• 20. Pregnant or lactating women; 21. People with known history of alcoholism or drug abuse; 22. Have uncontrollable complications, including but not limited to symptomatic congestive heart failure, uncontrollable hypertension, unstable angina, active peptic ulcer or hemorrhagic diseases; 23. History of interstitial lung disease or non-infectious pneumonia. Subjects who had previously had non-infectious pneumonia caused by drugs or radiation but had no symptoms were allowed to enter the group; 24. The QTcF interval is more than 450 msec, unless it is secondary to bundle branch block; 25. Past psychiatric history; incapacitated or restricted; 26. According to the researchers'judgment, patients' underlying condition may increase their risk of receiving research drug treatment, or confuse their judgment on toxic reactions; 27. Other researchers consider it unsuitable for patients to participate in this study.