Osteosarcoma
Conditions
Interventions
Experimental group:Intravenous infusion
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily joined the study, signed informed consent, good compliance, and cooperated with the follow-up; 2. Aged >=12 years, both men and women; 3. High-grade osteosarcoma (Ennecking stage II) diagnosed by histopathology, the patient has undergone radical surgery (R0 resection) and the investigator has confirmed that the adjuvant chemotherapy has been completed, and the adjuvant chemotherapy should be completed within 12 weeks; 4. Must have used two or more drugs in combination with chemotherapy regimen; Doxorubicin cumulative amount should be no less than 300mg / m2 (including converted dose); total preoperative and postoperative chemotherapy course should not be less than 12 times, postoperative chemotherapy start time is not After 30 days, postoperative chemotherapy should not exceed 32 weeks; 5. Eastern Cooperative Oncology Group (ECOG) score 0-1; 6. Expected survival >=3 months; 7. The functions of important organs meet the following requirements; (1) Absolute neutrophil count >=1.5x10^9/L; (2) Platelet count >=75x10^9/L; (3) Hemoglobin >=90g/L; (4) serum albumin >=28g/L; (5) Total bilirubin =50mL / min (using the standard Crockcroft-Gault formula); (7) Thyroid function: Thyroid stimulating hormone (TSH) is normal. If TSH is abnormal, FT3 and FT4 levels should be examined, and normal FT3 and FT4 levels can be selected; 8. Female subjects of childbearing age need to take effective contraception during the study period and within 3 months after the end of the study treatment period; female patients of childbearing age who are not surgically sterilized must have a negative serum HCG test within 7 days before study enrollment.
Exclusion criteria
Exclusion criteria: 1. Local recurrence or distant metastasis; 2. Active autoimmune disease or history of autoimmune disease (such as the following, but not limited to, interstitial pneumonia, uveitis, colitis, hepatitis, arthritis, nephritis, pituitary inflammation, hyperthyroidism, thyroid Hypofunction, etc.); but does not include autoimmune-mediated reduction in thyroid function with a stable dose of thyroid replacement hormone therapy; type I diabetes with a stable dose of insulin; vitiligo or cured childhood asthma / allergies, adult Patients who do not need medical intervention; 3. The subject is being treated with immunosuppressive agents, or systemic or absorbable local corticosteroids for immunosuppressive purposes (dose> 10 mg / day of prednisone or equivalent), and before enrollment Continue to be used within 2 weeks; 4. Have received any form of organ transplantation, including allogeneic stem cell transplantation; 5. Known previous allergy to macromolecular protein preparations, or known to be allergic to any ZKAB001 constituents; 6. Past or concurrently suffering from other malignant tumors (except malignant tumors that have been cured or cancer-free for more than 5 years, such as skin basal cell carcinoma, cervical carcinoma in situ, and papillary thyroid carcinoma); 7. There are clinical symptoms or diseases of the heart that are not well controlled, such as: NYHA Grade 2 or higher heart failure, unstable angina pectoris, myocardial infarction within 1 year, clinically significant supraventricular or ventricular arrhythmias requiring treatment or Left ventricular ejection fraction of resting patients with echocardiogram at rest was less than 50%; 8. Previously received radiotherapy, chemotherapy, surgery or molecular targeted therapy, less than 3 weeks after completion of treatment and before study medication; 9. Subject has active infection (requires use of antibacterial, viral, fungal drugs), or appears during the screening period and occurs within one week before the first dose of fever of unknown cause> 38.5 ? The fever produced by the tumor can be included in the group); 10. Positive test for human immunodeficiency virus (HIV), untreated active hepatitis B (hepatitis B surface antigen positive and peripheral blood HBV-DNA titer test >=1000IU / ml or a copy number positive value detected by the research center; Hepatitis C (Hepatitis C antibodies are positive and HCV-RNA is above the lower limit of detection of the analytical method); 11. Patients with active tuberculosis infection detected by medical history or CT examination, or patients with active tuberculosis infection history within 1 year before enrollment, or patients with active tuberculosis infection history but no formal treatment more than 1 year ago; 12. Subject is participating in other clinical studies, or less than 4 weeks before the end of the previous clinical study; 13. Subjects may receive other systemic anti-tumor treatments during the study period; 14. The subject has previously been treated with other PD-1 and / or PD-L1, or CTLA-4 antibodies, or other medications directed against immune receptor modulators; 15. Live vaccine received within 4 weeks before screening; 16. Subject is known to have a history of psychotropic substance abuse, alcohol or drug use; 17. Pregnant or lactating women; 18. Any mental condition that prevents understanding or the provision of informed consent; 19. At the discretion of the investigator, the patient has other fac
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease-free survival (DFS)); | — |
Secondary
| Measure | Time frame |
|---|---|
| 5-year overall survival (OS);safety;Immunogenicity;Relationship between tumor cell PD-L1 expression level and clinical efficacy; | — |
Countries
China
Contacts
Public ContactLiu Zhenhua
Outcome results
None listed