Sarcoma
Conditions
Interventions
Experimental Group:Doxorubicin + ifosfamide + sintilimab
Control group:Doxorubicin + ifosfamide
Sponsors
Shandong First Medical University Affiliated Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-70 years old, gender is not limited 2. Patients diagnosed with locally advanced or metastatic multiple undifferentiated sarcomas that cannot be treated locally (surgery or radiotherapy) by histological pathology and imaging examinations; 3. Patients who have not received anthracyclines and immune checkpoint inhibitors before; 4. According to RECIST version 1.1, there are measurable lesions at baseline; 5. ECOG performance status score (Appendix 2) is 0-1, and the expected survival period is more than 3 months; 6. Recovered from previous treatment: According to NCI-CTCAE version 5.0, all side effects (except hair loss) have subsided to grade 1 or below; 7. The main organ function is normal, that is, the following criteria are met: hemoglobin (Hb) >= 95g/L, neutrophil (ANC) >= 1.5×10^9/L, platelet count (PLT) >= 80×10^9/L, serum creatinine (Cr) = 35 g/L Prothrombin time (PT) and partial thromboplastin time (PTT) = 50% Blood pressure controlled within 140/90 mmHg before enrollment 8. Women of childbearing age must have taken reliable contraceptive measures or had a pregnancy test (serum or urine) within 7 days before enrollment, and the result was negative, and are willing to use appropriate contraceptive methods during the trial and 8 weeks after the last administration of the trial drug. For men, they must agree to use appropriate contraceptive methods or undergo surgical sterilization during the trial and within 8 weeks after the last administration of the trial drug. 9. Sign the informed consent form (or have the legal representative sign it) to prove that they understand the purpose of this study and the operations required by the study, and are willing to participate in this study.
Exclusion criteria
Exclusion criteria: 1. Any active autoimmune disease or history of autoimmune disease; 2. Other malignant tumors that occurred or are currently present within five years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)]; 3. Active infection requiring systemic treatment; 4. Uncontrolled cardiac clinical symptoms or diseases, such as: (1) NYHA grade 2 or above heart failure (2) unstable angina (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention (5) QTc>450ms (male); QTc>470ms (female); 5. Need to use cortisol (greater than 10 mg/day of prednisone or =Equivalent dose) or other systemic immunosuppressive drugs (except inhaled or topical corticosteroids) or prednisone or equivalents of replacement therapy at a dose greater than 10 mg/day; 6. Patients with objective evidence of interstitial lung disease in the past or currently; 7. Live vaccines received less than 4 weeks before study medication or may be administered during the study; 8. Pregnant or lactating women; 9. Known history of human immunodeficiency virus (HIV); 10. Known active hepatitis B or C; 11. Patients with known mental illness or substance abuse disorders; 12. Subjects judged by the investigator to have other factors that may lead to the forced termination of this study, such as severe laboratory test abnormalities, family or social factors, etc., which may affect the safety of the subjects, or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Overall Survival;Objective Response Rate; | — |
Countries
China
Contacts
Public ContactZhu Dongyuan
Shandong First Medical University Affiliated Cancer Hospital
Outcome results
None listed