Primary mediastinal Large B-Cell Lymphoma.
Conditions
Interventions
experimental group:tislelizumab injection combined with R-CHOP
Sponsors
Affiliated Tumor Hospital of Xinjiang Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pathology: primary mediastinal large B-cell lymphoma confirmed by histology (based on tumor histopathological specimens within 2 years before enrollment); 2. Aged 18-70 years old; 3. ECOG PS score 0-2; 4. The patient must have a target lesion with the longest diameter greater than 1.5 cm; 5. Treatment protocols: Patients with the disease are required 6 courses of tislelizumab + R-CHOP; 6. Sign the informed consent form and be able to comply with the visits and related procedures stipulated in the plan; 7. Estimated survival time >= 6 months; 8. Cardiac function: LVEF >= 50% detected by cardiac color Doppler ultrasound; 9. Hematopoietic functionWBC >= 4.0 x 10^9/L; ANC >= 2.0 x 10^9/L; PLT >=100 x 10^9/L; Hb >=90 g/L; 10. Liver function: Total bilirubin, ALT and AST are all = 50 ml/min; 12. Remarks: (1) Hematopoietic function, liver function, and renal function refer to the baseline level before any treatment. Patients who recover after treatment (including whitening, blood transfusion, etc.) can be included in the group. (2) Patients with chronic hepatitis B can be included in the group, but they need to receive entecavir antiviral therapy, HBV-DNA <10^4 copies before chemotherapy.
Exclusion criteria
Exclusion criteria: 1. Pathologically confirmed as gray zone lymphoma or high-grade B-cell lymphoma; 2. Previous treatment with any PD-1, PD-L1 or anti-CTLA-4 antibodies; 3. Having used immunosuppressant drugs within 4 weeks before the first dose of study treatment, excluding local glucocorticoids by nasal spray, inhalation or other routes or physiological doses of systemic glucocorticoids (ie <= 10mg/day prednisone or equivalent doses of other glucocorticoids); 4. Patients with known central nervous system violations; 5. Receiving live attenuated vaccine within 4 weeks before the first dose of study treatment or planning to receive live attenuated vaccine during the study period; 6. Having underwent major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks before the first dose of study treatment; 7. Active autoimmune disease or history of autoimmune disease within the past 2 years (Vitiligo, psoriasis, alopecia, or Grave's disease who do not need systemic treatment within the past 2 years, patients with hypothyroidism who only require thyroid hormone replacement therapy can be included in the group); 8. Known history of primary immunodeficiency; 9. Known to have active tuberculosis; 10. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 11. Untreated active hepatitis; 12. Previous allergic asthma or severe allergic disease; 13. Poorly controlled high blood pressure and diabetes; 14. Having a history of other tumors, except for cured papillary thyroid carcinoma or basal cell carcinoma of the skin; 15. Patients infected with HIV or syphilis; 16. Women who are pregnant or breastfeeding; 17. Having a history of severe neurological or psychiatric illness, including dementia or epilepsy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;Objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;safety;OS;safety;Progression free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactShujuan Wu
Affiliated Tumor Hospital of Xinjiang Medical University
Outcome results
None listed