Soft tissue sarcoma
Conditions
Interventions
Therapy group:Camrelizumab and chemotherapy
Sponsors
He'nan Tumor Hospital
Eligibility
Sex/Gender
All
Age
16 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 16-70 years, both male and female. 2. The physical condition score of the eastern cancer cooperation group (ECOG) is 0-1. Amputation subjects can be relaxed to 2 points. 3. Expected survival time >= 3 months. 4. Soft tissue sarcoma subjects with distant metastasis or local advanced stage and determined by the investigator to be unsuitable for surgical treatment (pathological subtypes include undifferentiated pleomorphic sarcoma, synovial sarcoma, leiomyosarcoma, angiosarcoma, clear cell sarcoma, epithelioid sarcoma, fibrosarcoma, undifferentiated/poorly differentiated liposarcoma). 5. Subjects with metastatic/surgically unresectable soft tissue sarcoma who have previously received systematic treatment or sensitive recurrence after chemotherapy (sensitive recurrence refers to recurrence more than 6 months after the last chemotherapy). 6. There are measurable lesions meeting RECIST 1.1 standard. 7. All acute toxicity caused by previous anti-tumor treatment or surgery shall be relieved to grade 0-1 (according to NCI-CTCAE version 4.03) or to the level specified in the inclusion/exclusion criteria before the first day of the first cycle (C1D1) (except for toxicity such as hair loss that the researchers believe does not pose a safety risk to the subjects). 8. Adequate organ and bone marrow function, as defined below: (1) Blood routine (no blood transfusion, no G-CSF, no drug correction within 14 days before screening): neutrophil count (ANC) >= 1500/mm^3 (1.5 x 10^9/L); platelet count (PLT) >= 100,000/mm^3 (100 x 10^9/L); hemoglobin (HB) >= 9 g/dl (90 g/L); (2) Blood biochemistry: serum creatinine (CR) = 60 ml/min; total bilirubin (TBIL) = 2+, the 24-hour urinary protein quantitative display protein must be <= 1 g. 10. Thyroid function: thyroid stimulating hormone (TSH) <= ULN; if the level of FT3 (T3) and FT4 (T4) is abnormal, it can be selected if the level of FT3 (T3) and FT4 (T4) is normal. 11. Female subjects of childbearing age must carry out serum pregnancy test within 7 days before medication, and the result is negative, and are willing to use a medically recognized high-efficiency contraceptive measure (such as IUD, contraceptive or condom) during the study period and within 3 months after the last administration of the study drug; male subjects whose partners were women of childbearing age needed surgical sterilization or agreed to use effective contraceptive methods during the study period and within 3 months after the administration of the last study. 12. Agreed and signed an informed consent form, willing and able to comply with planned visits, study treatments, laboratory tests and other experimental procedures.
Exclusion criteria
Exclusion criteria: 1. Received the following treatment within the previous 4 weeks: radiotherapy, surgery, chemotherapy, immune or molecular targeted therapy for tumors; other clinical research drugs; live attenuated vaccine. 2. Previously received PD-1/PD-L1/CTLA-4 antibody treatment. 3. Surgical treatment and or radiotherapy for soft tissue sarcoma are planned during the study period. 4. Imaging diagnosis showed that there were tumor lesions in the central nervous system. 5. Immunosuppressive drugs have been used in the first 14 days of c1d1, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (i.e. prednisolone not more than 10 mg/day or other corticosteroids of the same pharmacophysiological dose). 6. Any active autoimmune disease or history of autoimmune disease (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism and hypothyroidism; subjects with vitiligo or asthma that has completely relieved in childhood and does not need medical intervention at present can be included), or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 7. Severe infection (such as intravenous infusion of antibiotics, antifungal or antiviral drugs) within 4 weeks before C1D1, or unexplained fever > 38.5 degree during screening/before the first administration. 8. Hypertension, which cannot be well controlled by antihypertensive drugs (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg). 9. C1D1 had significant clinical bleeding symptoms or definite bleeding tendency within the first 3 months, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood + + and above, vasculitis, etc; or arteriovenous thrombosis events occurred within 6 months before C1D1, such as cerebrovascular accidents (including transient ischemic attack, intracerebral hemorrhage and cerebral infarction), deep venous thrombosis and pulmonary embolism; or long-term anticoagulant therapy with warfarin or heparin, or long-term antiplatelet therapy (aspirin >= 300 mg/day or clopidogrel >= 75 mg/day). 10. There was active heart disease within 6 months before C1D1, including myocardial infarction, severe/unstable angina pectoris, etc. Echocardiographic left ventricular ejection fraction 450 ms in men and > 470 ms in women). 11. C1D1 was diagnosed as any other malignant tumor within the first 3 years, except for fully treated basal cell or squamous cell skin cancer or cervical carcinoma in situ. 12. Known allergy to the study drug or any of its excipients; or have severe allergic reactions to other monoclonal antibodies. 13. human immunodeficiency virus (HIV) infection, active hepatitis B (hepatitis B surface antigen positive and HBVDNA >= 500 IU/ml), hepatitis C (hepatitis C antibody positive and HCV-RNA higher than the lower limit of the analytical method). 14. According to the researchers' judgment, there are serious risk factors for the safety of the subjects, which may confuse the findings, or affect the accompanying diseases (such as poorly controlled hypertension, severe diabetes, neurological or psychiatric disorders), or any other circumstances affecting the subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Progression free survival;Overall survival;Adverse event; | — |
Countries
China
Contacts
Public ContactWang Jiaqiang
He'nan Tumor Hospital
Outcome results
None listed