Camrelizumab Plus Doxorubicin for the First Line Treatment of Adcanced Soft Tissue Sarcoma

Inclusion Criteria:

• 1. Patients with advanced soft tissue sarcoma (pathologically confirmed undifferentiatedpleomorphic sarcoma/synovial sarcoma/leiomyosarcoma/liposarcoma) not suitable for surgery;

2. Aged ≥ 18 years old, < 60 years old; 3) Eastern Cooperative Oncology Group (ECOG)performance status score of 0-1, amputees can be 0-2; 4) Expected survival > 6 months; 5)Adequate organ and bone marrow function, defined as follows: ① Blood routine (14 daysbefore screening without blood transfusion, without G-CSF, without drug correction):neutrophil count (ANC) ≥ 1.5 × 10^9/L; platelet count (PLT) ≥ 100 × 10^9/L; hemoglobin (Hb) ≥ 100 g/L; ② Blood biochemistry: serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN)or creatinine clearance ≥ 60ml/min; total bilirubin (TBIL) ≤ 1.5 × ULN; aspartateaminotransferase (AST) or alanine aminotransferase (ALT) level ≤ 2.5 × ULN, The subjectswith liver metastasis should be ≤ 5 × ULN; ③ Coagulation function: international normalizedratio (INR) ≤ 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; ④ Urinalysis: urine protein < 2 +; if urine protein ≥ 2 +, the 24-hour urineprotein quantification must be ≤ 1g; ⑤ thyroid stimulating hormone (TSH) ≤ ULN and ≥ LLN;if abnormal, T3 and T4 levels should be investigated, normal T3 and T4 levels can beincluded.
3. ECG is basically normal, no myocardial ischemia performance, no history of arrhythmiarequiring drug intervention, echocardiography LVEF ≥ 50%; 7) no autoimmune diseases; 8) canprovide tissue samples for biological testing; 9) have measurable lesions according toRECIST1.1 criteria; 10）Agree and have signed informed consent, willing and able to complywith scheduled visits, study treatment, laboratory tests and other test procedures.^

Exclusion Criteria:

• 1. Patients who have previously received anthracycline treatment; 2) Patients who havepreviously received immunotherapy such as anti-PD-1, anti-PD-L1, anti-PD-L2,anti-CTLA4, etc.; 3) Patients who are known to be allergic to recombinant humanizedanti-PD-1 monoclonal antibody drugs and their components; 4) Patients with New YorkHeart Association (NYHA) score of more than II heart disease (including grade II); 5)Patients with mental or neurological disorders or do not cooperate; 6) Patients whohave received other anti-tumor therapy 4 weeks before enrollment, including but notlimited to surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.;

7. Patients who have used immunosuppressive drugs within 14 days before enrollment.Does not include nasal spray and inhaled corticosteroids or physiological doses ofsystemic steroids (i.e., no more than 10 mg/day prednisolone or other corticosteroidsat physiological doses of the same drug); 8) any active autoimmune disease or historyof autoimmune disease (subjects with vitiligo or asthma that has been completelyrelieved in childhood and currently does not require medical intervention can beincluded), or known history of allogeneic organ transplantation or allogeneichematopoietic stem cell transplantation.
8. Known allergy to the study drug or any of its excipients; or severe allergicreactions to other monoclonal antibodies; 10) Patients with central nervous systemmetastasis; 11) Patients with severe systemic infection (who need intravenousantibiotics, antifungal or antiviral drugs) within 4 weeks before enrollment, or bodytemperature ≥ 38.0℃; 12) Patients received live vaccination within 4 weeks before thestart of treatment; 13) HIV infection, HCV antibody positive and HCV RNA higher thanthe lower limit of detection of the analytical method, HBsAg or HBcAb positive and HBVDNA positive (quantitative detection limit of 500 IU/ml); 14) History of activepulmonary tuberculosis; 15) Patients who had been diagnosed with any other malignanttumor within 3 years before enrollment, except for adequately treated basal cell orsquamous cell skin cancer or cervical carcinoma in situ; 16) Pregnant women orlactating women, or patients who plan to become pregnant during the study period orwithin one year after the use of the study drug; 17) Patients who participating in thetrial is not in their best interest (such as endangering their health) or will hinderthe evaluation of the trial protocol.