Phase II Trial of Tirelizumab Combined With R2-ICE Regimen in the Treatment of rrDLBCL/HGBL

Inclusion Criteria:

1. Age range ≥16 years old, no gender limitation;
2. Diffuse large B-cell lymphoma or high-grade B-cell lymphoma (HGBL) was confirmed byhistopathology.
3. Have received prior first-line chemotherapy for DLBCL or HGBL, failed to reach CR infour cycles, or relapsed.
4. At least one positive lesion under 18F-deoxyglucose (18FDG) positron emission computedtomography (PET-CT) according to the 2014 Lugano criteria for Hodgkin's andnon-Hodgkin's lymphoma;
5. ECOG physical status score is 0-3;
6. At the time of screening, laboratory tests met the following criteria, unless theinvestigator could determine that lymphoma was the cause (no corrective and supportivetreatment for the parameters described below was performed within 2 weeks prior toevaluation) : (1) Routine blood test: Hemoglobin (Hb) ≥90g/L, absolute neutrophil (ANC) ≥1.5×109/L, platelet count (PLT) ≥90×109/L; (2) biochemical examination: serumcreatinine (Cr) ≤1.5× upper limit of normal value (ULN), creatinine clearance rate > 50ml/min (Cockcroft formula); Total bilirubin (TBIL) ≤1.5×ULN; Alanineaminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (livermetastasis: ≤5ULN).
7. Life expectancy was at least three months, the researchers judged;
8. Understand and voluntarily sign written informed consent.

Exclusion Criteria:

1. With central nervous system metastasis or piameningeal metastasis;
2. Prior organ transplant;
3. Previous or current combination of other malignant tumors, except adequately treatedbasal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of thecervix;
4. Patients who have been treated with PD-1 inhibtor before;
5. History of severe allergy to antibody drugs;
6. Those with active immune diseases, such as systemic lupus erythematosus;
7. Uncontrolled or significant cardiovascular disease, including: (1) New York HeartAssociation (NYHA) class II or higher congestive heart failure, unstable angina,myocardial infarction, or arrhythmia requiring treatment, or left ventricular ejectionfraction (LVEF) <50% at the time of screening within 6 months prior to initialadministration of the study drug; (2) primary cardiomyopathy (such as dilatedcardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricularcardiomyopathy, restricted cardiomyopathy, unshaped cardiomyopathy); (3) clinicallysignificant prolonged history of QTc interval, or screening QTc interval >470ms forwomen and >450ms for men; (4) symptomatic coronary heart disease requiring drugtreatment during screening period; (5) Other cardiovascular diseases deemed unsuitablefor inclusion by the investigator.
8. A history of severe interstitial lung disease (ILD), such as pulmonary fibrosis, orbaseline chest CT or MRI showing evidence of ILD;
9. Clinically significant gastrointestinal abnormalities that may affect drug intake,transport or absorption (such as inability to swallow, chronic diarrhea, intestinalobstruction, etc.), or total gastrectomy;
10. High-risk surgery for vital organs or poor healing of other surgical wounds asdetermined by the investigator 6 weeks prior to screening;
11. Active infection or active or uncontrolled HBV, HCV infection, HIV/AIDS (AcquiredImmune Deficiency Syndrome) or other serious infectious diseases (including: activeinfection requiring systemic treatment; HBV/HCV/HIV qualitative detection ispreferred, quantitative detection is required; HBV DNA can be included after treatmentto turn negative);
12. Any mental or cognitive impairment that may limit their understanding of informedconsent, performance of informed consent, and compliance with the study;
13. Drug and alcohol abuse;
14. Women of reproductive age who are unwilling or unable to use an effective method ofcontraception during the entire treatment period of the trial and within 12 weeks ofthe last Tirelizu administration or within 12 months of the last rituximabadministration, whichever is the latest [women of reproductive age include: Any womanwho has menstruated and has not undergone successful artificial sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or has not beenmenopausal], is pregnant or breastfeeding;
15. Other conditions that the investigator considers inappropriate for participation inthe study.