Adriamycin and Ifosfamide Combined With Sintilimab

Inclusion Criteria:

1. Patients voluntarily participated in the study and signed informed consent; All advanced or non resectable soft tissue sarcomas confirmed by pathology failed ordid not have standard treatment or could not tolerate standard treatment, Have atleast one according to RECIST 1.1 the standard measurable lesions mainly includedsynovial sarcoma, leiomyosarcoma, alveolar soft tissue sarcoma, undifferentiatedpleomorphic sarcoma / malignant fibrous histiocytoma, liposarcoma, fibrosarcoma, clearcell sarcoma, angiosarcoma, epithelioid sarcoma, malignant peripheral nerve sheathtumor, undifferentiated sarcoma, dermatofibrosarcoma protuberans, inflammatorymyofibroblastic sarcoma Malignant solitary fibroma, sarcoma after radiotherapy.However, there are no standard treatment types, such as alveolar soft tissue sarcoma,post radiotherapy sarcoma, highly differentiated / dedifferentiated / pleomorphicliposarcoma, clear cell sarcoma, etc.; except for the following types: chondrosarcoma,osteosarcoma, malignant mesothelioma, gastrointestinal stromal tumor, etc;
2. Advanced patients with unresectable lesions or lymph nodes or distant metastasisassessed by imaging;
3. In the past three months, there was at least one measurable target lesion according toRECIST version 1.1 standard, and it can be accurately measured by magnetic resonanceimaging (MRI) or computer tomography (CT) in at least one direction (the maximumdiameter needs to be recorded), with conventional CT ≥ 20 mm or spiral CT ≥ 10 mm.
4. They were 14-70 years old; ECoG PS score: 0-1; the expected survival time was morethan 3 months;
5. Within 7 days before treatment, the main organ functions met the following criteria:

(1) Blood routine examination standard (without blood transfusion within 14 days)

① Hemoglobin (HB) ≥ 90g / L;

② The absolute value of neutrophil (ANC) ≥ 1.5 × 109 / L;

• Platelet (PLT) ≥ 80 × 109 / L. (2) Biochemical examination should meet the following standards: ① Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); ② Alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5uln, such as With liver metastasis, ALT and AST ≤ 5uln;

③ Serum creatinine (CR) ≤ 1.5uln or creatinine clearance rate (CCR) ≥ 60ml / min;

(3) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ the lowerlimit of normal value (50%). Women of childbearing age should agree that contraceptive measures (such as intrauterinedevice, contraceptive or condom) must be used during the study period and within 6 monthsafter the end of the study; serum or urine pregnancy test negative within 7 days beforestudy enrollment, and must be non lactating patients; men should agree that contraceptivemeasures must be used during the study period and within 6 months after the end of thestudy period.

Exclusion Criteria:

1. Patients who had previously received anti-PD-1 / PD-L1 antibody therapy.
2. Other malignancies occurred or were present within 5 years, except for cervicalcarcinoma in situ, non melanoma skin cancer and superficial bladder tumor [ta (non invasivetumor), tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)];
3. The patients with thyroid dysfunction after the best drug treatment;
4. Systemic anti-tumor therapy including cytotoxic therapy, signal transduction inhibitors,immunotherapy (or mitomycin C within 6 weeks prior to the trial drug treatment) was plannedwithin 4 weeks before enrollment or during the study period. Over extended fieldradiotherapy (ef-rt) was performed within 4 weeks before admission or limited fieldradiotherapy (rfrt) was performed within 2 weeks before grouping;
5. With pleural effusion or ascites, it causes respiratory syndrome (≥ CTC AE grade 2dyspnea [grade 2 dyspnea refers to shortness of breath with a small amount of activity; itaffects instrumental activities of daily living]);
6. Any unrelieved toxic reaction higher than CTC AE (4.01) grade 1 or above caused byprevious treatment, excluding alopecia;
7. Patients with any severe and / or uncontrolled disease, including:

1. Patients with poor blood pressure control (SBP ≥ 150 mmHg, DBP ≥ 100 mmHg);
2. Patients with myocardial ischemia or myocardial infarction of grade I or above,arrhythmia (including QTc ≥ 480ms) and congestive heart failure (NYHA) grade ≥ 2;
3. Active or uncontrolled severe infection (≥ CTC AE Level 2 infection);
4. Chronic liver disease, decompensated liver disease or decompensated hepatitis;
5. Renal failure needs hemodialysis or peritoneal dialysis;
6. Poor control of diabetes mellitus (FBG > 10mmol / L);
7. Urine routine examination showed that urine protein was ≥ + +, and 24-hour urineprotein was more than 1.0 G;
8. Patients with epilepsy and need treatment;

8. Major surgical treatment, open biopsy or obvious traumatic injury were performed within 28 days before admission;
9. Patients with any physical signs or history of bleeding regardless of severity; patientswith any bleeding or bleeding events ≥ CTCAE 3 within 4 weeks before enrollment hadunhealed wounds, ulcers or fractures;
10. Patients who had AVT events within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism;
11. There were active ulcer, intestinal perforation and intestinal obstruction;
12. Subjects with clinical symptoms of central nervous system metastasis (such as brainedema, need for hormone intervention, or brain metastasis progression); patients who havepreviously received treatment for brain or meningeal metastasis, such as clinical stability (MRI) for at least 2 months, and who have stopped systemic hormone therapy (dose > 10mg /day, prednisone or other effective hormones) for more than 2 weeks can be included;
13. The subjects were using immunosuppressive agents, or systemic or absorbable localhormone therapy to achieve the purpose of immunosuppression (dosage > 10mg / D, prednisoneor other effective hormones), and continued to use them within 2 weeks before enrollment;
14. Subjects with any active autoimmune disease or history of autoimmune diseases (e.g.,but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis,vasculitis, nephritis, hyperthyroidism, hypothyroidism; if the subject has vitiligo orasthma has been completely relieved in childhood, it is not necessary to be an adult Anyintervention can be included; asthma patients who need bronchodilator for medicalintervention cannot be included);
15. The subjects had active tuberculosis;
16. According to the judgment of the researcher, the subjects are not suitable to beenrolled or there are other factors that may lead to termination of the study, such asother serious diseases (including mental diseases) requiring combined treatment, seriouslaboratory examination abnormalities, and family or social factors, which will affect thesafety of the subjects, or the collection of test data and samples;
17. Patients who participated in other clinical trials of anti-tumor drugs within 28 daysbefore enrollment.