Prostate cancer
Conditions
Interventions
test group:SBRT and Camrelizumab
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years. 2. ECOG PS score: 0-1 points. 3. Patients with advanced prostate cancerdiagnosed by pathology. 4. Have received previous surgery, endocrine therapy and/or chemotherapy with disease progression (including imaging progression or PSA progression). 5.At least one evaluable metastatic lesion; SBRT can be performed at leastonefractionat a dose that meets the limit of organs at risk. 6.Expected survival time> 3 months. 7.The functions of vital organs meet the following requirements: (1) Hemoglobin (Hb) >= 80 g/L (no blood transfusion within 14 days); The absolute count of neutrophils (ANC) >= 1.5 x 10^9 /L, platelets (PLT) >= 100 x 10^9 /L; (2)Total bilirubin (TBil) = 60mL/min; (4)Thyroid-stimulating hormone (TSH) < 1 ULN (if abnormal, T3 and T4 levels should be examined at the same time, if T3 and T4 levels are normal, they can be included in the group). 8. The subject voluntarily joined the study and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of allergies to Camrelizumab. 2. Central nervous system metastasis with clinical symptoms such as cerebral edema which need hormone intervention, or progression of brain metastasis. 3. Have a history of other malignant tumors within 5 years or at the same time; 4. Failure to control clinical symptoms or diseases of thecardiac, such as: (1) according to the New York Heart Association (NYHA) Standard class II or higher heart failure (2) unstable angina (3) myocardial infarction occurred within 1 year (4) patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention. (1) Have received any of the following treatment: (2) Previous treatment with anti-PD-1, anti-PD-L1 antibodies or anti-CTLA-4 antibodies; (3) Received any investigational drug within 4 weeks prior to initial study drug use; (4) Enrolled in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or an interventional follow-up of a new clinical study; (5) Subjects requiring systematic treatment with corticosteroids (greater than 10mg equivalent daily dose of prednisone) or other immunosuppressant within 2 weeks prior to first use of the study drug, except where corticosteroids are used for local inflammation and for the prevention of allergy and nausea and vomiting. In the absence of active autoimmune disease, inhaled or topical corticosteroid and adrenocorticosteroid replacement at doses greater than 10mg/ day as a therapeutic dose of prednisone are allowed. (6) Have received an anti-tumor vaccine or a live vaccine within 4 weeks prior to the first administration of the investigational drug; F. Major surgery or severe trauma within 4 weeks prior to initial study drug use. 6. Severe infections (CTC AE > grade 2), such as severe pneumonia, bacteremia, and infection complications requiring hospitalization, occurred within 4 weeks before the first use of the study drug; Baseline chest imaging suggests active pulmonary inflammation, signs and symptoms of infection within 2 weeks before the first use of study drug, or the need for oral or intravenous antibiotic therapy (excluding prophylactic use of antibiotics). 7. Have a history of active autoimmune diseases, autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes); Autoimmune of hypothyroidism treated with a steady dose of thyroid replacement hormone; Use of steady doses of insulin in type 1 diabetes; This does not include patients with vitiligo or childhood asthma/allergies that have been cured and who do not need any intervention as adults. 8. Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of the organ and bone marrow transplants. 9. Have a history of interstitial lung disease and non-infectious pneumonia. 10. Patients with a history of active TB infection or with a history of active TB infection within 1 year before enrolment, or patients with a history of active TB infection before 1 year but without formal treatment. 11. Patients with active hepatitis (HBV DNA >= 2000IU/ml or 10000 copies/ml), hepatitis C (positive HCV antibody and HCV-RNA above the detection limit of assay method). 12. Have a known history of psychotropic substance abuse, alcoholism and dru
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate, ORR;time to PSA progression;overall survival, OS; | — |
Countries
China
Contacts
Public ContactShoumin Bai
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Outcome results
None listed