prostate cancer
Conditions
Interventions
Test group:Tirelizumab
Sponsors
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Patients with a clinical diagnosis of mCRPC who have failed treatment with at least 1 but no more than 2 novel endocrine agents (abiraterone acetate or novel AR antagonists such as enzalutamide, apatamide, SHR3680, etc.) according to the EAU-EANM-ESTRO-ESUR-SIOG 2020 guidelines; Patients who failed chemotherapy (imaging progression or PSA progression) were enrolled; Patients with previous chemotherapy intolerance or refusal were allowed to be enrolled; 2) Prostate adenocarcinoma is confirmed by histological examination and small cell carcinoma is excluded, and the diagnosis must be stated in the pathology report and confirmed by the investigator; 3) Imaging evidence of metastatic disease: soft tissue lesion metastasis and/or bone lesion identified by computed tomography (CT)/ magnetic resonance imaging (MRI)/ PET-CT, as well as other organ metastases, including but not limited to liver, lung, brain, etc.; 4)Patients with mutations in germ lines or systems of DNA defect repair genes confirmed by next generation seqence, Previous detection results included at least BRCA2, BRCA1, ATM, PALB2, FANCL, RAD51B, RAD51C, RAD51D, BRIP1, BRAD1, CHEK1, CHEK2, CDK12, RAD54L germ line and system mutation detection. 5)ECOG score 0-2; 6)The patient had normal organ function, WBC=3000/mm3 or neutrophil absolute count greater than 1500/mm3, platelets greater than 100×109/L, hemoglobin greater than 100 g/L, AST and ALT less than 1.5 ULN (within 7 days of initial administration), AKP less than 2.5ULN, Less than 5ULN and serum creatinine less than 1.25ULN with bone metastasis 7)Age 18 or older and 75 or younger at the time of signing the informed consent; 8)The investigators expected the patients to survive longer than 3 months; 9)The patient agrees to and is able to follow the planned study visit, provide pre - and post-treatment blood samples, provide clinical information, and cooperate with other study procedures.
Exclusion criteria
Exclusion criteria: 1)Other malignancies are known to be progressing or require aggressive treatment; 2)Have active autoimmune disease that has required systemic treatment in the past two years; 3)Have a history of (non-infectious) pneumonia requiring steroid treatment, or currently have pneumonia; 4)Congenital or acquired immune deficiency (such as HIV infection); 5)Have active hepatitis (hepatitis B: HBsAg positive and HBV DNA=500 IU/ml; Hepatitis C: HCV antibody positive and HCV virus copy number exceed the upper limit of normal); 6)Subjects must recover from major surgery or severe trauma requiring general anesthesia at least 14 days before the study treatment begins; 7)Less than 1 year after remission of grade 2 toxicity associated with targeted pelvic therapy (e.g., radiation enteritis); 8)Have myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or a history of such disease; 9)Symptomatic congestive heart failure (New York Heart Association Class III or IV heart disease); 10)Have received prior bone marrow allograft or double umbilical cord transplantation (dUCBT) or solid organ transplantation; 11)Cytochrome P450 3A4 enzyme (CYP3A4) suppressant preparations including itraconazole, clarithromycin, voriconazole, tellymycin, saquinavir and ritonavir were received within 2 weeks before admission; 12)Lack of access to clinical information needed for the study (such as patients lost to follow-up); 13)Conditions considered unsuitable for inclusion by other researchers, such as alcoholism, drug abuse, other serious medical conditions (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, and family or social factors, may affect the safety of patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSA Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;safety; | — |
Countries
China
Contacts
Public Contactdongbaijun
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Outcome results
None listed