prostate cancer
Conditions
Interventions
experimental group:Camrelizumab combined with Fluzoparib
Sponsors
The Second Hospital of Tianjin Medical University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Adult male, >= 18 years old; 2. Histologically or cytologically proven prostate adenocarcinoma; 3. Imaging evidence of metastatic disease: metastases of soft tissue lesions demonstrated by computed tomography/magnetic resonance imaging (CT/MRI) and/or bone lesions identified by bone scans; 4. During or after the most recent treatment prior to screening, disease progression was identified according to PCWG3 criteria, defined as one or more of the following 3 criteria: 1) PSA progression: elevated PSA levels at least 1 week between at least 2 measurements.Screening stage PSA >= 1ug/L (1ng/mL); 2) Soft tissue lesion progression as defined by RECIST 1.1; 3) Bone lesion progression: in line with PCWG3 "2+2" definition: at least two new lesions were found during bone scan, and reconfirmed >= 6 weeks later; 5. Has received androgen deprivation therapy (LHRH agonist or antagonist or bilateral orchiectomy), serum testosterone = 12 weeks; 10. The function of vital organs meets the following requirements (no blood component or cell growth factor correction therapy was used within 14 days before the first medication) : A) Absolute neutrophils count >= 1.5 x 10^9/L; B) Platelet >= 100 x 10^9/L; C) Hemoglobin >= 100 g/L; D) Serum albumin >= 30g/L; E) Thyroid stimulating hormone (TSH) <= 1 x ULN (if abnormal, FT3 and FT4 levels should be examined at the same time; if FT3 and FT4 levels are normal, they can be included in the group); F) Bilirubin <= 1 x ULN (within 7 days before the first medication); G) ALT and AST <= 3 x ULN (within 7 days before the first medication); H) AKP <= 2.5 x ULN, < if accompanied by bone metastasis;5 x ULN; I) Serum creatinine <= 1.25 x ULN; 11. Fertile male participants must agree to use appropriate contraception from the beginning of the first dose of study therapy until 120 days after the last dose of study therapy; 12. Participate in the study voluntarily and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Other malignancies known to be progressing or requiring aggressive treatment during the past 3 years; 2. Has an active autoimmune disease and has required systemic treatment in the past two years; 3. Have a history of (non-infectious) pneumonia requiring steroid treatment, or have current pneumonia; 4. Suffers from congenital or acquired immune deficiency (such as HIV infection); 5. Have active hepatitis (HBV reference: HBsAg positive and HBV DNA >= 500 IU/ml;Hepatitis C reference: HCV antibody positive and HCV virus copy number > Upper limit of normal value); 6. Patients with brain metastasis; 7. Previous systemic, radical brain or meningeal metastasis therapy (radiotherapy or surgery), stable for at least 1 month as confirmed by imaging, and no systemic hormone therapy (dose > Patients with 10mg/ day of prednisone or other equal-efficacy hormones) for more than 2 weeks and no clinical symptoms were included; 8. Subjects must have recovered from major surgery or severe trauma requiring general anesthesia at least 14 days before study treatment begins; 9. Less than 1 year after >= 2 grade toxicity related to pelvic targeted therapy (such as radiation enteritis) remission; 10. Previous surgery (excluding prostate biopsy), radiotherapy, chemotherapy, or other anti-tumor therapy (excluding ADT), less than 4 weeks before the first trial medication after the completion of treatment (last medication);With the exception of hair loss and fatigue, toxicity from all previous anticancer treatments must be reduced to level 1 or baseline before administration of the study drug; 11. A history of consciousness loss within 12 months after screening; 12. Have or have a history of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML); 13. Diagnosis of immunodeficiency or chronic systemic steroid treatment; 14. Allergies (>= grade 3) to carrizumab and/or any of its excipients; 15. Known allergy to the ingredients or excipients in fluzopalil; 16. Symptomatic congestive heart failure (New York Heart Association Grade III or IV heart disease); 17. Prior anti-cancer monoclonal antibody therapy (mAb); 18. Previous treatment with fluzopalil or any other PARP inhibitor; 19. Have received anti-PD-1, anti-PD-L1 or anti-CTLA-4 drugs; 20. During the 2 weeks before enrollment, he received cytochrome P4503A4 enzyme (CYP3A4) inhibitory agents: itraconazole, clarithromycin, voriconazole, tirimycin, saquinavir, ritonavir, etc.; 21. Previous bone marrow allograft or double umbilical cord (DUCBT) or solid organ transplantation; 22. Live vaccines should be given within 30 days of the date of random allocation. 23. According to the researcher's judgment, patients have other factors that may affect the results of the study or cause the study to be terminated midway, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring combined treatment, severe laboratory examination abnormalities, accompanied by family or social factors, which will affect the safety of patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| duration of response;time to response;disease control rate;progress-free survival of radiation;survival rate 6m, 12m;duration of PSA response; | — |
Countries
China
Contacts
Public ContactYuanjie Niu
The Second Hospital of Tianjin Medical University
Outcome results
None listed