chondrosarcoma
Conditions
Interventions
Aponermin injection group:Each cycle lasts for 14 days. Aponermin treatment is administered at a dose of 10mg/kg via intravenous infusion on days 1 to 5.
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Patients fully understand this study, voluntarily participate in it and sign the Informed Consent Form (ICF). 2) Age: between 18 and 75 years old (including the boundary values of 18 and 75 years old). 3) Patients with chondrosarcoma whose chondrosarcoma subtype has been histologically confirmed and who have evidence of progression within 6 months. 4) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 - 2 points. 5) Laboratory test data requirements within 7 days (including 7 days) before screening: neutrophil count >= 1.5 × 10?/L, platelet count >= 90 × 10?/L, hemoglobin >= 90 g/L (without blood transfusion within 14 days), serum total bilirubin = 50 ml/min. 6) Having measurable lesions (according to the RECIST 1.1 criteria).
Exclusion criteria
Exclusion criteria: 1) Having received any experimental drugs or anti-tumor drugs within 4 weeks before enrollment. 2) Having symptomatic brain or meningeal metastases (unless the patient has received treatment for > 6 months, the imaging results were negative within 4 weeks before entering the study, and the clinical symptoms related to the tumor were stable at the time of entering the study). 3) Having a history of previous allogeneic organ transplantation. 4) Having clinically significant and severe active bleeding. 5) Pregnant or lactating women; those with fertility who have not taken adequate contraceptive measures. 6) Having alcoholism or drug addiction. 7) Having failure of vital organ functions or other serious diseases, including interstitial pneumonia, clinically relevant coronary artery disease, cardiovascular disease or having had a myocardial infarction, congestive heart failure, unstable angina pectoris, significant pericardial effusion or unstable arrhythmia within 6 months before enrollment, severe thrombosis, including pulmonary embolism, visceral embolism, deep vein thrombosis, etc. 8) Having abnormal cardiac function, including: long QTc syndrome or QTc interval > 480 ms; complete left bundle branch block, second-degree or third-degree atrioventricular block (except after pacemaker implantation treatment); having severe, uncontrolled arrhythmia requiring drug treatment; having a history of chronic congestive heart failure and NYHA >= grade 3; having a left ventricular ejection fraction lower than 50% within the previous 6 months; having cardiac valvular disease with CTCAE >= grade 3; having uncontrolled hypertension (defined as systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg measured multiple times under drug control); having a history of myocardial infarction, unstable angina pectoris, severe pericardial disease within 6 months before screening, having electrocardiogram evidence of acute ischemic or severe active conduction system abnormalities. 9) Having a history of being infected with the human immunodeficiency virus or suffering from other acquired or congenital immunodeficiency diseases. 10) Patients with active chronic hepatitis B or active hepatitis C. HBV carriers, those with hepatitis B stabilized after drug treatment (DNA titer <= 10³ copies/ml) and patients with cured hepatitis C (negative HCV RNA test) can be enrolled. 11) Suffering from any serious and/or uncontrollable diseases, or other diseases that, as judged by the investigator, may affect participation in this study (including but not limited to, a history of severe neurological or psychiatric disorders that are not effectively controlled, severe infections, diabetes, kidney diseases requiring dialysis, severe liver diseases, life-threatening autoimmune diseases and bleeding disorders, drug abuse, neurological diseases, etc.). 12) Being allergic to the drug components of Aponermin. 13) Other circumstances judged by the investigator as being inappropriate for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR, objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 4-month Progression-Free Survival; | — |
Countries
China
Contacts
Public ContactHUA YINGQI
Shanghai General Hospital
Outcome results
None listed