prostate cancer
Conditions
Interventions
Treating Group:Sullimumab: intravenous injection, 200mg each time, administered once every 3 weeks. Until disease progression (PD) or medication for 1 year.
Ankerui: Intraprostatic injection, 1 × 10 ^
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-80 years old; 2. Patients with metastatic castration resistant prostate cancer who develop resistance to standard treatment, including those who have received new endocrine drugs or chemotherapy, and have not undergone radical prostatectomy. Castration resistant prostate cancer is defined as: when the serum testosterone level is below 50ng/ml in a state of androgen deprivation, at least one of the following conditions still occurs: (1) three consecutive increases in serum PSA levels with an absolute value of >= 2ng/ml; (2) Advances in imaging; (3) Symptoms worsen. 3. ECOG score: 0-1 points; 4. Expected survival period >= 3 months; 5. The main organ functions are normal, which meets the following criteria: (1) The blood routine examination standards must meet the following criteria (no blood transfusion or blood products within 14 days, no use of G-CSF or other hematopoietic stimulating factors correction): a. HB >= 90 g/L; b.ANC >=1.5×10^9/L; c.PLT >=80×10^9/L; (2) Biochemical tests must meet the following standards: a. TBIL45 ml/min (Cockcroft Gault formula); 6. It is necessary to agree to use appropriate methods of contraception or surgical sterilization during the trial period and 8 weeks after the last administration of the trial drug; 7. The subjects voluntarily joined this study and signed an informed consent form, with good compliance and cooperation with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients who have undergone radical prostatectomy; 2. Those who have received chemotherapy within 3 weeks, radiation therapy or immunotherapy within 6 weeks, those who have used immunosuppressants or have autoimmune diseases, and those who have had malignant tumors other than prostate cancer within 5 years. 3. Patients with organ failure; 4. ECOG >2 points; 5. Persons with uncontrollable infectious diseases or other serious diseases, such as HIV positive, active hepatitis; 6. Patients with systemic autoimmune diseases or immunodeficiency diseases; 7. Patients with allergies or chronic diseases that require immunotherapy or hormone therapy; 8. Uncontrollable hypertension (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg, despite optimal drug treatment); 9. Suffering from grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval >= 450 ms in males); 10. According to NYHA standards, patients with grade III-IV cardiac dysfunction or those with left ventricular ejection fraction (LVEF)1.5 or prothrombin time (PT)>ULN+4 seconds or APTT>1.5 ULN), with a tendency to bleed or undergoing thrombolytic or anticoagulant therapy; 12. Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or similar drugs; 13. Within the first 2 months of randomization, there was a significant cough of fresh blood or a daily hemoptysis volume of half a teaspoon (2.5ml) or more; 14. Within the first 3 months of randomization, there have been significant clinical bleeding symptoms or clear bleeding tendencies, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood++or above, or vasculitis; 15. Arterial/venous thrombotic events that occurred within the first 12 months of randomization, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; 16. Known genetic or acquired bleeding and thrombophilia tendencies (such as in hemophilia patients, coagulation dysfunction, thrombocytopenia, splenic hyperfunction, etc.); 17. Long term untreated wounds or fractures; 18. Have undergone major surgical procedures or experienced severe traumatic injuries, fractures, or ulcers within the first 4 weeks of randomization; 19. Urine routine test indicates urinary protein >=++, or confirms 24-hour urinary protein level >= 1.0 g; 20. Serous fluid accumulation (including pleural effusion, ascites, and pericardial effusion) with clinical symptoms that require surgical treatment; 21. Patients with active hepatitis B or C virus infection; 22. Active infections that require antimicrobial therapy (such as treatment with antibiotics, antiviral drugs, or antifungal drugs); 23. Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders; 24. Those who have participated in clinical trials of other anti-tumor drugs within 4 weeks before enrollment; 25. In cases where the researcher determines that other factors may affect the progress of clinical research and the determination of research results, it is allowed to use low-dose heparin (daily dosage for adults is 6000-12000 U) or low-dose aspirin (daily dosage <= 100 mg) for preventive purposes;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiological progression free survival;Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;disease control rate;Changes in immune microenvironment; | — |
Countries
China
Contacts
Public ContactHua Wang
Zhejiang Cancer Hospital
Outcome results
None listed