undifferentiated pleomorphic sarcoma
Conditions
Interventions
group 1:Drug intervention
Sponsors
Peking University Cancer Hospital
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged >=16 years old, male or female; 2. Eastern Cooperative Oncology Group (ECOG) physical status score of 0-1; 3. Advanced undifferentiated pleomorphic sarcoma (UPS) confirmed by histopathology, who have not received systemic therapy for metastatic or advanced disease, adjuvant therapy (received anthracycline therapy) recurrence within 6 months except; 4. There are lesions that can be assessed by imaging, according to the solid tumor response evaluation criteria (RECIST 1.1), at least one single-diameter measurable lesion, the longest diameter of which is measured by spiral CT >= 10 mm; 5. If subjects have undergone major surgery, they must have fully recovered from complications before starting treatment; 6. The function of major organs is normal, that is, the following criteria are met: (1) The blood routine examination standards must be met (no blood transfusion and blood products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors): 1) Hemoglobin (Hb) >= 9 g/L; 2) The number of neutrophils (ANC) >= 1.5x10^9/L; 3) Platelet count (PLT) >= 80x10^9/L; (2) The biochemical examination shall meet the following standards: 1) Total bilirubin (TBIL) = 60 ml/min. 7. International Normalized Ratio (INR) <= 1.5, Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) <= 1.5 times ULN (this applies only to patients not receiving therapeutic anticoagulation; receiving therapeutic anticoagulation Patients on anticoagulation should take a stable dose) 8. Women of childbearing age must have taken reliable contraceptive measures or performed a pregnancy test (serum or urine) within 7 days before enrollment, and the results are negative, and are willing to use appropriate methods during the trial and 60 days after the last administration of the trial drug contraception. For males, consent to use an appropriate method of contraception or be surgically sterilized during the trial and within 120 days after the last dose of the trial drug; 9. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. The patient has any active autoimmune disease or has a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis , hyperthyroidism; patients with vitiligo; asthma has been completely resolved in childhood, without any intervention in adulthood can be included; patients with asthma requiring bronchodilator medical intervention can not be included); 2. Past (within 5 years) or concurrently suffering from other malignant tumors (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; for patients with recurrent ovarian cancer combined with breast cancer in the past, no disease for > 3 years after radical mastectomy) except for relapses); 3. Known active central nervous system (CNS) metastases and/or cancerous meningitis. Subjects previously treated for brain metastases may participate as long as they remain stable and meet the following criteria: no evidence of radiographic progression for at least four weeks prior to the first dose of trial treatment, and any neurological symptoms have returned to baseline, no Evidence of new or enlarging brain metastases and no steroid use for at least 7 days prior to trial treatment. This exception excludes cancerous meningitis, regardless of its clinical stability. 4. The use of immunosuppressive drugs within 14 days before the first use of camrelizumab, excluding nasal and inhaled corticosteroids or systemic steroids at physiological doses (ie, no more than 10 mg/day of prednisolone or other corticosteroids at equivalent pharmacological doses); 5. Previous therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or against another stimulating or synergistic inhibitory T cell receptor (eg, CTLA-4, OX-40, CD137) drug; 6. Severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia (including QTc interval >= 450 ms for men and >= 470 ms for women); grade III to IV cardiac insufficiency (according to New York Heart Association NYHA classification, see Appendix 3), or echocardiography showed left ventricular ejection fraction (LVEF) 38.5°C during the screening period/before the first dose; 9. Received major surgical operations or suffered severe traumatic injury, fracture or ulcer within 4 weeks before enrollment; 10. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active tuberculosis, active hepatitis B (HBsAg positive and HBV DNA >= 500 IU/ml), hepatitis C ( HCV antibody positive and HCV virus copy number > upper limit of normal) or co-infection of hepatitis B and C; 11. Patients who have received organ transplantation in the past (except corneal transplantation); 12. Known or suspected allergy to the study drug or any drug related to this trial; 13. Less than 4 weeks before the study medication or may be vaccinated with live vaccines during the study period; 14. Those who may receive other systemic anti-tumor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival; | — |
Countries
China
Contacts
Public ContactFan Zhengfu
Peking University Cancer Hospital
Outcome results
None listed