Bone and soft tissue sarcoma
Conditions
Interventions
Neoantigen vaccination group:Neoantigen vaccination on day 1, 4, 8, 15, 22, 43, 64, 85, 106, in the dose of 0.5mg prptides/ 200µL once, subcutaneously inject in the deltoid muscle of both upper arms a
Sponsors
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Eligibility
Sex/Gender
All
Age
12 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged at least 12 and less than 75 years old, ECOG performance status score of 0 to 1, have an estimated life expectancy of at least 3 months; 2. Specimen puncture or surgical resection was performed in Nanjing Drum Tower Hospital, and had a pathologically confirmed bone and soft tissue sarcoma with a typical driving mutation. Patients with localized bone and soft tissue tumors with intermediate or high risk of recurrence can receive neoantigen vaccine immunotherapy to prevent recurrence during adjuvant therapy. Patients with metastatic, recurrent or unresectable advanced bone and soft tissue tumors can receive other treatments at the same time. 3. Have at least one lesion suitable for immunotherapy estimated by RECIST v1.1 or iRECIST; 4. Functions of important organs conform to the following requirements: ? leokocyte count >= 3×10^9/L, lymphocyte >= 0.8×10^9/L; absolute neutrophil count >= 1.5×10^9/L; ? Hemoglobin >= 9g/dL; ? Platelets >= 90×10^9/L; ? Bilirubin = 30 mL/min (standard Cockcroft -Gault formula is applied) ? Left ventricular ejection fraction (LVEF) >=50%; ? International normalized ratio (INR) < 1.5, and activated partial thromboplastin time (APTT) <1.5×ULN. 5. Women of childbearing age should have a negative pregnancy test (serum or urine) within 14 days before enrollment, and to have voluntary contraception from enrollment to 3 months after last dose of the study drug. Men should have either surgical sterilization or consent to contraception during the observation period and for 3 months after the last dose of study medication; 6. Patients aged 18 years and above who voluntarily participated in the study and had signed the informed consent, and were willing to follow the study protocol and follow-up process; patients aged 14 years and above, with the consent of their guardians, voluntarily participated in the study and had signed the informed consent, and were willing to follow the study protocol and follow-up process; for patients younger than 14 years of age, their guardians agreed to participate in the trial, provided written informed consent, and were willing to follow the protocol and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. Have received major operation within 4 weeks ahead of enrollment; 2. With serious hypertension (blood pressure >= 150/100 mmHg) that cannot be controlled through medical treatment 3. With uncontrolled cardiovascular symptoms or diseases, including: congestive heart failure > NYHA grade II, unstable angina, history of myocardial infarction within the past 12 months, serious arrhythmia, clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 4. Have any active autoimmune disease or a history of autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (eligible after hormone replacement therapy)); patients with complete remission of childhood asthma without any intervention in adulthood or with vitiligo were eligible. Patients requiring medical intervention with bronchodilators were not eligible. 5. Have congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA>=500 IU/ml), hepatitis C (hepatitis C antibody positive and HCV-RNA higher than the detection limit of the assay) or co-infection with hepatitis B and C; 6. Severe infection (e.g., needing intravenous antibiotic, antifungal, or antiviral therapy) within 4 weeks before the first dose or unexplained fever >38.5 ° C during screening/before the first dose; 7. Arterial/venous thrombosis events occurred within 6 months before enrollment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; 8. Allergy to any trial drug; 9. Pregnant, lactating patients, and patients with reproductive capacity unwilling to take effective contraceptive measures; 10. Patients with history of neurological or psychiatric disorders, including epilepsy and dementia; 11. Uncontrolled or symptomatic active central nervous system (CNS) metastases, with clinical symptoms of cerebral edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, and/or progressive growth; 12. Other conditions deemed unsuitable for inclusion by the investigator. Including, but not limited to, accompanying family or social factors that may affect the safety of the subjects or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity of comprehensive immunootherapy based on neoantigen vaccine; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year disease-free survival rate;Dose limiting toxicity; | — |
Countries
China
Contacts
Public ContactLi Rutian
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Outcome results
None listed