Undifferentiated pleomorphic sarcoma and myxofibrosarcoma
Conditions
Interventions
Experimental group:Preoperative treatment: Doxorubicin liposomes, 50mg/m2, intravenously, once every 3 weeks. On the basis of the above chemotherapy regimen, Ptrelizumab was added to the treatment reg
Sponsors
Shanghai Changzheng hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Have fully understood the study and voluntarily signed the informed consent; 2. Age 18-75 years old (inclusive), male and female; 3. Pathologically and/or cytologically confirmed undifferentiated pleomorphic sarcoma or myxofibrosarcoma with a tumor diameter greater than 5 cm, or with a tumor diameter less than 5 cm but with difficult resection of stage 1 R0, which is not expected to achieve satisfactory surgical margins or may cause serious functional impairment; 4. Have not received anti-tumor therapy such as chemotherapy, targeted therapy, immunotherapy and local radiotherapy; 5. Have at least one measurable lesion according to RECIST (V1.1) criteria; 6. The physical status score of Eastern Tumor Collaboration Group (ECOG) was 0-2 points; 7. Major organ function meets the following criteria before treatment (no blood transfusion, EPO, G-CSF, etc., within 14 days before screening period) : Blood routine: absolute neutrophil count = 1.5 × 109 /L; Platelet = 100 × 109 /L; Hemoglobin = 90g/L; Renal function: serum creatinine = 1.5 × upper limit of normal range (ULN); Liver function: total bilirubin = 1.5 ×ULN (patients with liver metastasis, bile duct obstruction or confirmed Gilbert syndrome: = 3×ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 × ULN (liver metastases: = 5 × ULN); Coagulation function: International standardized ratio (INR) or prothrombin time (PT) = 1.5 × ULN; Partially activated thromboplastin time (APTT) : = 1.5 × ULN; 8. Expected survival =3 months; 9. Women of childbearing age must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment; Both men and women were required to voluntarily use effective contraception during the study period.
Exclusion criteria
Exclusion criteria: 1. Complicated with other malignant tumors (patients who have finished anti-tumor therapy and no tumor recurrence or metastasis within 2 years can be included in this study); 2. Had a major surgical procedure or had not fully recovered from any previous invasive procedure within 4 weeks prior to the first use of the study drug; 3. Received systemic use of glucocorticoids (prednisone > 10mg/ day or equivalent dose of the same drug) or other immunosuppressants within 2 weeks prior to the first use of the study drug (except for the following: Treatment with topical, ocular, intraarticular, intranasal and inhaled glucocorticoids; short-term use of glucocorticoids for preventive treatment (e.g. to prevent hypersensitivity to contrast media)]; 4. Had infection within 2 weeks prior to enrollment and required systemic (oral or IV) anti-infective therapy (except for uncomplicated urinary tract infections or upper respiratory tract infections); 5. Use of inactivated or live attenuated vaccine or novel coronavirus vaccine within 4 weeks prior to the first use of the investigational drug; 6. Accompanied by serious medical problems, such as: Cardiovascular diseases such as grade III and above cardiac dysfunction (NYHA criteria), ischemic heart disease (e.g., myocardial infarction or angina), poorly controlled diabetes (fasting blood glucose =10 mmol/L), poorly controlled hypertension (systolic blood pressure >140 mmHg and/or diastolic blood pressure >90 mmHg), Echocardiography showed that ejection fraction was less than 50%. 7. The tumor has clear and active brain metastases; 8. Patients with chest/ascites or pericardial effusion accompanied by clinical symptoms or need symptomatic treatment; 9. Patients with a history of serious lung disease, such as interstitial lung disease and/or pneumonia, or pulmonary hypertension, or a history of severely impaired lung function; 10. Patients with abnormal thyroid function, but if the thyroid function is normal after drug control, they are allowed to enter the group; 11. Active hepatitis B, active hepatitis C virus infection or active syphilis infection. Active hepatitis B: Hepatitis B surface antigen (HBsAg) positive and HBV-DNA quantitative titer = 2000IU/mL. If HBsAg is positive, HBV-DNA in peripheral blood is < 2000IU/mL, and if the investigator believes that the subject's chronic hepatitis B is stable and does not increase the risk of the subject, the subject is eligible for enrollment. Active hepatitis C: anti-HCV positive and HCV RNA positive; Active syphilis infection: positive for treponema pallidum antibodies (RPR or TRUST) or the presence of a syphilis infection that requires systemic treatment; 12. A history of autoimmune diseases (other than tuberous sclerosis), a history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 13. According to the judgment of the researcher, the patient is not eligible to participate in this clinical study because of concomitant diseases (such as uncontrollable hypertension, active gastrointestinal bleeding, etc.) or other reasons that seriously endanger the safety of the patient and affect the completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological response rate;Event-free survival;Overall Survaval; | — |
Countries
China
Contacts
Public ContactCheng Yang
Shanghai Changzheng hospital
Outcome results
None listed