osteosarcoma
Conditions
Interventions
experimental group:chidamide combined with tislelizumab
Sponsors
Beijing Jishuitan Hospital
Eligibility
Sex/Gender
All
Age
11 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=11 years, no gender limit; 2. Advanced classic osteosarcoma confirmed by histopathology; 3. Patients with recurrence during postoperative adjuvant chemotherapy or within 1 year after the end of chemotherapy, with only lung metastases that cannot be surgically removed (defined as more than 5 lung lesions) or patients without surgical treatment; 4. No second-line treatment, PD-1 or PD-L1 treatment or HDAC inhibitor treatment in the past; 5. At least one measurable lesion at baseline (according to RECIST v1.1 assessment criteria); 6. ECOG physical strength score 0-1; 7. Neutrophils >=1.5x10^9/L, platelets >=100x10^9/L, hemoglobin >=90g/L; 8. Functions of other organs shall be satisfied: (1) Cardiac function should be satisfied: left ventricular ejection fraction >=50%, no organic arrhythmia; (2) Liver function requirements: ALT and AST<=2.5 times the upper limit of normal, total bilirubin <=1.5 times the upper limit of normal; (3) Renal function should meet: creatinine <=1.5 times the upper limit of normal; (4) Coagulation function: International Normalized Ratio (INR) <=1.5 times ULN; Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) <=1.5 thrombin time ULN (unless the patient is receiving anticoagulant therapy and PT and APTT are within the expected range of anticoagulant therapy at the time of screening); (5) Thyroid function: thyrotropin (TSH) or free thyroxine (FT4) or free triiodothyronine (FT3) were within the normal range of ±10%; 9. Can provide tumor pathological tissue specimens (wax block or 2~3 micron thickness of 5 white pieces); 10. The expected survival time is more than 3 months; 11. Volunteer to participate in this clinical trial and sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. A history of interstitial lung disease or pneumonia requiring oral or intravenous steroids; 2. Have received or will receive live vaccine (seasonal influenza vaccine without live vaccine is allowed), had/received major surgical procedures within 30 days prior to the first study treatment; 3. Clinically confirmed meningeal metastasis, spinal cord compression, or brain metastasis with central nervous system symptoms; 4. Active infection [any major infection event requiring intravenous antibiotic therapy, or targeted antiviral therapy, or hospitalization with an active bacterial, viral, fungal, mycobacterium, parasitic or other infection (excluding nail bed infection) within 4 weeks prior to the screening period], or persistent fever within 14 days prior to screening; 5. A history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 6. Significant cardiovascular disease that cannot be controlled; A history of clinically significant prolonged QT interval, or a QTc interval >450 ms during the screening period, or concomitant diseases (such as severe hypertension, diabetes, thyroid disease, active infection, etc.) that, in the investigator's judgment, seriously endanger the subject's safety or affect the subject's completion of the study; 7. Subjects of childbearing age who tested positive for baseline pregnancy tests in pregnant or lactating women or fertile women, or who did not want to use effective contraception for at least 120 days, whether male or female, between the time they enrolled in the study and the last time they took the study drug; 8. Received immunosuppressive drugs, excluding nasal spray, inhalation or other routes of topical glucocorticoids or physiological doses of systemic glucocorticoids (i.e., no more than 10mg/ day of prednisone or equivalent doses of other glucocorticoids), or hormones to prevent hypersensitivity to contrast media within the first 4 weeks of inclusion; 9. Conditions deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 4-month progression-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Duration of response;Clinical benefit rate;Safety; | — |
Countries
China
Contacts
Public ContactNiu Xiaohui
Beijing Jishuitan Hospital
Outcome results
None listed