PCNSL
Conditions
Interventions
A:ICIs
Sponsors
the second hospital of Dalian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Men and women aged 18 or above; 2. Patients with pathologically confirmed primary central nervous system lymphoma (PCNSL) who relapsed after at least one systematic treatment: Recurrence was defined as the development of a new lesion at the primary site or another site after a complete response (CR) with standard treatment containing MTX; 3. Requirements for measurable lesion scanning: Patients should have at least one measurable extranodal lesion (greater than 10 x 10mm); 4. The Eastern Collaborative Oncology Group (ECOG) scale score was 0-2; 5. The functions of vital organs meet the following requirements (1)> Blood routine: neutrophil count >= 1.5 x 10^9/L; Platelet count >= 75 x 10^9/L; Hemoglobin >= 90g/L; (2)> Liver function: TBIL Renal function: creatinine (Cr) Thyroid stimulating hormone (TSH) within the normal range; If TSH is abnormal, free triiodothyronine (FT3) and free thyroxine (FT4) must be normal or abnormal without clinical significance (ICIs cohort only); 6. Understand the procedure and content of the trial, and sign the informed consent voluntarily;
Exclusion criteria
Exclusion criteria: Patients with any of the following exclusion criteria were excluded from the study 1. (1) patients with suspected or existing ocular tumors; (2) Patients who cannot be evaluated by enhanced MRI; (3) Patients with central nervous system lymphoma complicated with extensive systemic invasion; 2. A history of other malignancies within the last 3 years, except locally curable cancers (limited to basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast); 3. Those who were judged not suitable for inclusion by the researcher; In the case of an ICIs cohort, patients who presented with any of the following were also excluded from the study 4. Patients with the following autoimmune diseases, such as active autoimmune diseases, type I diabetes mellitus, hypothyroidism requiring hormone replacement (other than Hashimoto's thyroiditis); 5. use of immunosuppressive agents, systemic or local hormone therapy (systemic corticosteroid with a daily dose equivalent to prednisone >10mg) to achieve immunosuppression within 14 days before the first dose; 6. The patient has a history of organ transplantation or allogeneic bone marrow transplantation, or has received autologous stem cell transplantation within 3 months before the first dose, or has other severe immune deficiency; 7. Known patients with previous allergy to macromolecular protein preparations or known anti-PD-1 /PD-L1 antibodies; 8. Active infected persons requiring systemic treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Countries
China
Contacts
Public ContactXian Zhang
the second hospital of Dalian Medical University
Outcome results
None listed