undifferentiated polymorphic sarcoma
Conditions
Interventions
Group 1 :Tislelizumab, 200 mg, every three weeks
Sponsors
Beijing Jishuitan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 18-75 years old, gender is not limited; 2. Pathologically confirmed unresectable locally advanced or metastatic undifferentiated pleomorphic sarcoma (UPS), with at least one measurable lesion; 3. Have not previously received systemic chemotherapy or immunotherapy for advanced tumors; 4. Evaluate according to the activity status score table [1] developed by Eastern Cooperative Oncology Group (ECOG), and include patients with ECOG score 0-1 ; 5. Adequate organ function: (1) Blood routine (no blood product transfusion, no use of granulocyte colony-stimulating factor, no correction of other drugs within 14 days before treatment): 1) Neutrophil count (NE) > 1.5 x 10^9/L; 2) Hemoglobin count (HGB)> 90 g/L; 3) Platelet count (PLT) > 100 x 10^9/L; (2) Coagulation function (no transfusion of blood products within 14 days before treatment): international normalized ratio (INR) or prothrombin time (PT) = 30 mL/min; 2) Total bilirubin (TBIL) <= 1.5 x ULN; 3) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 x ULN, if the patient has liver metastasis, this standard is AST and ALT <= 5 x ULN; 6. Be able to provide written informed consent (ICF), and be able to understand and agree to abide by the research requirements and evaluation schedule; 7. Fertile patients must be willing to take highly effective contraceptive measures during the study period and within 120 days after the last dose of tislelizumab.
Exclusion criteria
Exclusion criteria: 1. Previously received immune checkpoint inhibitor therapy, such as anti-programmed death-1 (PD-1)/PD-1 ligand ( PD-L1) monoclonal antibody, cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody; 2. Symptomatic patients with brain metastases, cancerous meningitis, spinal cord compression, or brain or leptomeningeal diseases found in imaging CT or MRI at the time of screening (brain metastases that have completed treatment 4 weeks before enrollment and have stable symptoms without progression Patients can be enrolled, but they need to be evaluated by brain MRI, CT or venography to confirm that there are no symptoms of cerebral hemorrhage); 3. Accompanied by refractory pleural effusion or ascites, such as pleural effusion or ascites that requires puncture drainage within 2 weeks before the first administration; 4. There have been or are currently suffering from other malignant tumors in the past 2 years, cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors (Ta (non-invasive tumor), Tis (in situ tumor) carcinoma) and T1 (tumor invading basement membrane)); 5. Allergy to any research drug or excipient; 6. Untreated chronic hepatitis B or HBV carriers with chronic hepatitis B virus (HBV) DNA exceeding 500 IU/mL, or patients with active hepatitis C virus (HCV) infection; 7. There is any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, thyroid function Hyperthyroidism, hypothyroidism), or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, or patients who are considered by other investigators to have an impact on the study treatment; 8. Long-term use of hormones or other immunomodulators in large quantities; 9. Active infection; 10. Received live vaccines or attenuated vaccines within 30 days before the first dose of tislelizumab, or planned to receive live vaccines or attenuated vaccines during the study; 11. Overactive/venous thrombosis events occurred within 6 months, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism; 12. Suffering from severe cardiovascular diseases: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia; according to NYHA standards (Appendix III), grade III-IV cardiac insufficiency, or echocardiography showing left ventricular ejection Blood fraction (LVEF) < 50%; 13. History of interstitial lung disease or uncontrollable systemic diseases, including diabetes, hypertension, acute lung disease, etc.; 14. Known human immunodeficiency virus (HIV) infection; 15. Any major surgery requiring general anesthesia was performed within <= 28 days before the first administration; 16. There is an underlying medical condition or alcohol/drug abuse or dependence that is not conducive to the administration of the study drug, or may affect the interpretation of the results, or cause the patient to have a high risk of treatment complications; 17. Participate in another therapeutic clinical study at the same time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| 6 months progression free survival rate;Objective response rate;Disease Control Rate;Progression-free survival;Overall survival;Duration of response; | — |
Countries
China
Contacts
Public ContactXiaohui Niu
Beijing Jishuitan Hospital
Outcome results
None listed