Soft Tissue Sarcoma
Conditions
Interventions
experiment group:Camrelizumab Plus Doxorubicin
control group :Doxorubicin
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects with advanced soft tissue sarcoma (undifferentiated pleomorphic sarcoma / synovial sarcoma / non-uterine leiomyosarcoma / liposarcoma (excluding well-differentiated liposarcoma) confirmed by pathology) who are considered unsuitable for surgical treatment by the investigator / fibrosarcoma (excluding dermatofibrosarcoma protuberance); 2. Age >=18 years old; 3. The Eastern Cooperative Oncology Group (ECOG) physical status score is 0-1, which can be relaxed to 2 for amputees; 4. Expected survival > 3 months; 5. Adequate organ and bone marrow function, defined as follows: (1) Blood routine (no blood transfusion, no G-CSF, no drug correction within 14 days before screening): neutrophil count (ANC) >= 1.5 x 10^9/L; platelet count (PLT) >= 100 x 10^9 /L; Hemoglobin (Hb) >=90g/L; (2) Blood biochemistry: serum creatinine (Cr) = 60 ml/min; total bilirubin (TBIL) =2+, 24-hour urine protein quantification shows that protein must be =LLN; if abnormal, T3 and T4 levels should be investigated, and normal T3 and T4 levels can be selected. 6. The electrocardiogram is basically normal, there is no manifestation of myocardial ischemia, there is no history of arrhythmia requiring drug intervention, and the LVEF is greater than or equal to 50% by cardiac color Doppler ultrasound; 7. No autoimmune disease; 8. There are measurable lesions that meet the RECIST1.1 standard; 9. With my consent and signed informed consent, willing and able to comply with the planned visits, research treatments, laboratory examinations and other experimental procedures; 10. Females of childbearing potential must have a blood pregnancy test with a negative result within 72 hours before the first dose, and voluntarily use appropriate methods of contraception during the observation period and within 90 days after the last treatment; for males, it should be surgical sterilization, Or agree to use appropriate methods of contraception during the observation period and within 90 days after the last administration of treatment.
Exclusion criteria
Exclusion criteria: 1. Patients who have received anthracycline therapy in the past; 2. Previously received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4 and other immunotherapy, and other anti-tumor biological agents, chemical drugs, traditional Chinese medicine, Chinese patent medicine, etc.; 3. Those who are known to be allergic to recombinant humanized anti-PD-1 monoclonal antibody drugs and their components; 4. Patients with heart disease of grade II or above (including grade II) identified by the New York Heart Association (NYHA) score; 5. Those who suffer from mental or nervous system disorders or who do not cooperate; 6. Received other anti-tumor treatments within 4 weeks before enrollment, including but not limited to surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.; 7. Use of immunosuppressive drugs within 14 days before enrollment, excluding nasal and inhaled corticosteroids or systemic steroids at physiological doses (ie, no more than 10 mg/day of prednisolone or other corticosteroids at the same physiological dose of drugs) ); 8. No antibiotics were used in the 4 weeks before enrollment. 9. The existence of any active autoimmune disease or history of autoimmune disease (subjects with vitiligo or asthma that has been completely resolved in childhood and currently do not require medical intervention can be included), or known history of allogeneic organ transplantation or allogeneic History of hematopoietic stem cell transplantation. 10. Known to be allergic to the study drug or any of its excipients; or to have had a severe allergic reaction to other monoclonal antibodies; 11. Patients with central nervous system metastasis; 12. Patients with severe systemic infection (such as intravenous infusion of antibiotics, antifungal or antiviral drugs) within 4 weeks before enrollment, or patients with body temperature >= 38.0 degree; 13. Those who received live vaccine within 4 weeks before the start of treatment; 14. HIV infection, HCV antibody positive and HCV RNA higher than the detection limit of the analytical method, HBsAg or HBcAb positive, and HBV DNA copy number positive (quantitative detection limit is 500IU/ml); 15. Have a history of active pulmonary tuberculosis; 16. Diagnosed with any other malignant tumor within 3 years before enrollment, except for fully treated basal cell or squamous cell skin cancer or cervical carcinoma in situ; 17. Pregnant or lactating women, or patients who plan to become pregnant during the study period or within one year after the last use of the study drug; 18. Patients whose participation in the trial is not in the best interests of the subjects (eg, jeopardizing their health) or under any circumstances that would interfere with the evaluation of the trial protocol, in the investigator's opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Overall Survival;Duration of Response;Adverse event; | — |
Countries
China
Contacts
Public ContactChen Jing
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed