Osteosarcoma
Conditions
Interventions
5mg/kg:Intravenous infusion
10mg/kg:Intravenous infusion
15mg/kg:Intravenous infusion
Sponsors
the Sixth People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Voluntary participation and signed informed Consent letter; 2. Aged 18 to 55 years; 3. Histological diagnosis of high grade osteosarcoma(AJCC stage I-III).Patients had to undergo neoadjuvant chemotherapy and adjuvant chemotherapy and underwent primary radical surgery (R0), and adjuvant chemotherapy ended no more than 12 weeks.The chemotherapy regimen must include the THP (ADM)/epirubicin (EPI)/pyrrole ()/villous (PLD) and cisplatin (DDP), and the minimum cumulative dose for the above drugs is ADM 360mg/m2,epi450mg/m2,thp300mg/m2, PLD 240mg/m2 and DDP 480mg/m2; 4. ECOG=1 or 2, life expectancy of >3 months; 5. According to the program definition, the blood, liver and kidney function are good, satisfies the laboratory examination result: Neutrophil Absolute Count =1.5 x 10^9/l; Platelet =80x10^9/l; Hemoglobin =90g/l; Blood albumin =28g/l; bilirubin = 1.5 times times uln; Alt and Straw transaminase = 1.5 times times uln; Serum cr=1.25xuln or endogenous creatinine clearance rate =50ml/min (Applied standard Crockcroft-gault formula); 6. Women in childbearing age are required to take effective contraceptive methods during the study period and 3 months after the end of the treatment period, and female patients with non surgical sterilization must have negative serum or urine hCG within 7 days of trial enrollment.
Exclusion criteria
Exclusion criteria: 1. Local recurrence or distant metastasis; 2. There is a history of any active autoimmune disease or autoimmune disease (such as, but not limited to, interstitial pneumonia, uveitis, enteritis, hepatitis, arthritis, nephritis, hypophysitis, hyperthyroidism, hypothyroidism, etc.); Subjects with vitiligo or childhood asthma, still need medical intervention after adults; subjects need bronchodilators for medical interventions in asthma; 3. Subjects were using immunosuppressive agents, or systemic or absorbable topical corticosteroids, to achieve immunosuppressive purposes (doses of >10mg/-day prednisone or equivalent), and continued to be used within the first 2 weeks of trial enrollment; 4. Have received any form of organ transplantation, including allogeneic stem cell transplantation; 5. Known for previous large-molecule protein inhibitors or known to be allergic to any ZKAB001 component; 6. Within 5 years, there have been other malignant tumors other than the target disease of this trial, except for basal and squamous cell carcinoma of the skin; 7. Clinical manifestations of central nervous system metastasis (such as brain edema, brain metastases require corticosteroid-like drug intervention). Previous treatment for brain or meningeal metastases, such as clinical stability (MRI) not up to 2 months, or systemic corticosteroids (doses >10mg/day prednisone or equivalent) less than 2 weeks; 8. Having a heart clinical symptom or disease that is not well controlled, such as: NYHA 2-grade heart failure, unstable angina pectoris, myocardial infarction in 1 years, clinically significant ventricular or ventricular arrhythmia needs to be treated or interfered with, echocardiography shows left ventricular ejection fraction of 50%; 9. Prior therapy with radiotherapy, chemotherapy, surgery or molecular targeted therapy less than 3 weeks before the study, adverse events from prior treatment did not return to patients with = CTCAE grade 1, except for hair loss; 10. Subjects with active infections, or during the screening period, with unexplained fever >38.5 degree C within one week before the first dose (diagnosis by the investigator, subjects may be enrolled in the trial because of tumor-induced fever); 11. Human immunodeficiency virus (HIV) test positive, Treponema pallidum positive, untreated active hepatitis; 12. Subjects were enrolled in other clinical studies, or were less than 1 months before the end of a previous clinical trial; 13. Patients may undergo other systemic anti-tumor therapy during the trial 14. History of other PD-1 and/or PD-L1, or CTLA-4 antibody therapy, or molecular targeted drug therapy, or other drug therapy for immune-mediated receptor formulations; 15. Vaccination of live vaccines within 4 weeks of trial enrollment; 16. Current, active or previous history of psychotropic substance abuse, heavy alcohol abuseor drug addiction; 17. Pregnant or lactating women; 18. Any mental state impeding the understanding or provision of informed consent; 19. At the discretion of the investigator, the patient had other factors that may have caused the study to be terminated midway, such as other serious illnesses or severe laboratory abnormalities or other factors that may affect the safety of the subjects, or the family or society of the test data and sample collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of dose restrictive toxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Tolerated Dose; | — |
Countries
China
Contacts
Public ContactLiu Zhenhua
Zhaoke (Guang Zhou) Oncology Pharmaceutical Limited
Outcome results
None listed