Undifferentiated pleomorphic sarcoma
Conditions
Sponsors
Affiliated Tumor Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70, male and female. 2. ECOG score of physical condition was 0-1. Amputation subjects can be relaxed to 2 points. 3. Expected survival time >= 6 months. 4. Newly diagnosed sarcomas (previously untreated or untreated with no radiotherapy or immunotherapy and recurrent within 6 months after chemotherapy) or locally recurrent or low-homeostasis lesions that can be treated with radiotherapy; Oligometastatic sarcoma (defined as less than or equal to 3 detectable lesions); Detectable sarcomas that are scheduled to be treated with conventional fractionated radiotherapy prior to resection. 5. I agree and have signed the informed consent, and I am willing and able to follow the planned visit, research treatment, laboratory examination and other test procedures. 6. Suitable for surgical treatment of pleomorphic undifferentiated sarcoma of the subjects (including: pleomorphic undifferentiated sarcoma, unclassified spindle cell sarcoma, did not specify other spindle cell sarcoma, multiformity of spindle cell sarcoma, fibroblasts pleomorphic sarcoma, undifferentiated high-level pleomorphic sarcoma, with giant cell pleomorphic sarcoma, malignant fibrous histiocytoma (including star polymorphic and inflammatory subtype), fibrosarcoma and myxoid fibrosarcoma (at least a medium level; Deep in the muscle fascia). See annex 1.2013 WHO classification of soft tissue tumors for details. Resectable tumors were defined as those without significant vascular, nerve or bone involvement. Surgical excision should be performed only when it is safe to do so. Before the surgery, the anesthesia team will evaluate the patient for tolerable surgery. 7. Have a measurable lesion that meets RECIST1.1 standard. 8. Adequate organ and bone marrow functions, defined as follows: Blood routine (no transfusion, no g-csf, no drug correction within 14 days before screening): Neutrophil count (ANC) >= 1,500/mm3(1.5 x 10^9/L); Platelet count (PLT) >= 100,000/mm3(100 x 10^9/L); Hemoglobin (Hb) >= 9g/dL(90g/L); Blood biochemical: Serum creatinine (Cr) = 60ml/min; Total bilirubin (TBIL) = 2+, 24-hour urine protein quantitative display protein must be <= 1g; 10. Thyroid function: thyroid stimulating hormone (TSH) <= ULN; If abnormal, FT3(T3) and FT4(T4) levels should be considered, while normal FT3(T3) and FT4(T4) levels could be selected. 11. Female subjects of childbearing age must undergo a serum pregnancy test within 7 days prior to the use of the drug, which results in a negative outcome, and be willing to use a medically approved highly effective contraceptive (e.g., intrauterine contraceptive device, contraceptive pill or condom) during the study period and within 3 months after the last use of the study drug; For male subjects whose partners are women of childbearing age, surgical sterilization is required, or consent to use an effective method of contraception during the study period and within 3 months after the last study administration. 12. I agree and have signed the informed consent, and I am willing and able to follow the planned visit, research treatment, laboratory examination a
Exclusion criteria
Exclusion criteria: 1. Received the following treatment in the first 4 weeks of C1D1: Radiotherapy, surgery (except needle biopsy), chemotherapy, immunotherapy or molecular targeted therapy for the tumor. Other clinical research drugs. Get live attenuated vaccine. 2. Previous treatment with pd-1 / pd-l1 / ctla-4 antibody. 3. Surgical and/or radiation treatment for soft tissue sarcoma is planned during the study period. 4. Unresectable sarcomas, including severe vascular, nerve or bone involvement, and cases where complete surgical resection is not safe. 5. Any history of distant metastatic disease (including brain metastasis); If all other criteria are met, an isolated or oligometastatic lesion may be allowed. 6. Previous use of immunosuppressive drugs during the first 14 days of C1D1 does not include nasal and inhaled corticosteroids or systemic corticosteroids of physiological dose (i.e., no more than 10mg/ d prednisone or other corticosteroids of equivalent drug physiological dose). 7. Any active autoimmune diseases or a history of autoimmune diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism and hypothyroidism); Subjects with vitiligo or asthma that was completely relieved in childhood and currently does not require medical intervention could be included), or had a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 8. Severe infection within the first 4 weeks of C1D1 (if iv antibiotics, antifungal or antiviral drugs are required) or unexplained fever during screening /prior to initial administration. 9. Hypertension, which cannot be well controlled by antihypertensive drugs (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg). 10. Within the first 3 months of C1D1, there were significant clinical bleeding symptoms or clear bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, baseline stool occult blood ++ and above, vasculitis, etc. Or arteriovenous thrombosis within the first 6 months of C1D1, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism; Long-term anticoagulant therapy with warfarin or heparin or long-term antiplatelet therapy (aspirin >= 300mg/ d or clopidogrel >= 75mg/ d) may be required. 11. Active heart disease, including myocardial infarction, severe/unstable angina, etc. occurred in the 6 months before C1D1. Echocardiography left ventricular ejection fraction 450ms for males and > 470ms for females). 12. C1D1 has been diagnosed with any other malignancies within the first 3 years, except basal or squamous cell skin cancer or cervical carcinoma in situ, which has been adequately treated. 13. Severe allergic reactions to the drug or any of its excipients have been known to occur, or to other monoclonal antibodies. 14. Known history of active tuberculosis (mycobacterium tuberculosis), human immunodeficiency virus (HIV) infection, active hepatitis b (positive for hepatitis b surface antigen and HBVDNA >= 500IU/ml), hepatitis c (positive for hepatitis c antibody and hcv-rna higher than the lower limit of assay). 15. According to the judgment of the investigator, there are any conditions that seriously endanger the safety of th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Genomic and immunological analyses of gene-patient specimens and blood, based on independent pathological assessments of the percentage of residual tumor cells, hyaline and tumor necrosis, and changes in the proliferation of phosphohistone H3;Immune infiltration of surgical specimens before and after treatment (CD8, CD4, pd-l1, PD1, CD3, CD163 and FoxP3 positive cells);ORR (according to RECIST 1.1) and DCR (according to RECIST 1.1) based on investigator and independent imaging evaluation;OS;Incidence and severity of adverse events (AE) and severe adverse events (SAE), vital signs, electrocardiogram, and laboratory abnormalities.; | — |
Countries
china
Contacts
Public ContactJiaqiang Wang
Affiliated Tumor Hospital of Zhengzhou University
Outcome results
None listed