Prostate cancer
Conditions
Interventions
treatment group:Tislelizumab combined with platinum-based chemotherapy
Sponsors
Cancer Center, Sun Yat-Sen University
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent form (ICF): must be able to provide a written informed consent form and be able to understand the nature, significance and consequences of participating in this clinical study; 2. Agree not to participate in other interventional studies during tislelizumab treatment; 3. If you need to receive bisphosphonates or approved bone-targeted therapy, you must use tislelizumab at a stable dose for >= 28 days before the first day of administration; 4. Adult males >= 18 years of age at the time of signing the informed consent form, and signed the informed consent form before conducting any research-related activities in accordance with local guidelines; 5. Prostate adenocarcinoma confirmed by histology or cytology, or poorly differentiated adenocarcinoma without neuroendocrine differentiation; 6. Metastatic castration-resistant prostate cancer (mCRPC) meets one or both of the following conditions: (1) Measurable lesions assessed according to the Curative Effect Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Appendix 2), including internal organs (lung, liver, adrenal glands or others) and/or extrapelvic lymph nodes (retroperitoneal, mediastinum, thoracic cavity or other); (2) Bone lesions; 7. The progression of prostate cancer is defined as follows: (1) Prostate-specific antigen (PSA) progression: PSA rises >=3 consecutive times with a detection interval >=1 week; (2) PSA>=2 µg/L (2 ng/mL) during the screening period; 8. Has undergone surgery or medical castration treatment (bilateral orchiectomy or continuous treatment with gonadotropin releasing hormone [GnRH] agonists or antagonists, respectively); 9. Serum testosterone =1 line of androgen receptor targeted therapy for mCRPC (such as enzalutamide, abiraterone acetate/prednisone, bicalutamide, flutamide, apalutamide or nilumi special); 11. Have received >=1 line of taxa-based treatment for metastatic castration-resistant prostate cancer; 12. Agree to provide tumor tissue (if any) and blood samples for molecular analysis; 13. The Eastern Cooperative Oncology Group (ECOG) physical status score = 1.5x10^9/L; (2) Platelet count >= 100x10^9/L; (3) Hemoglobin >= 9 g/dL (>= 28 days after using growth factors or blood transfusion); (4) Glomerular filtration rate estimated according to the formula of Chronic Kidney Disease Epidemiology Cooperative Group (CKD-EPI) >= 30 mL/min/1.73 m^2; (5) Serum total bilirubin <= 1.5x upper limit of normal (ULN); (6) Aspartate aminotransferase and alanine aminotransferase are both <=3 x ULN; 16. The non-sterilized male patients participating in the study and the female partners of non-sterilized male patients must agree to take effective contraceptive measures during the study period and at least 6 months after the last dose of tislelizumab. Male patients who have not been sterilized are not allowed to donate sperm during the study period and for at least 6 months after the last administration of tislelizumab; 17. Life expectancy is greater than 12 weeks.
Exclusion criteria
Exclusion criteria: 1. Have received PD1/PDL1 immunoumab therapy in the past; 2. Have received platinum chemotherapy in the past; 3. Existence of uncontrollable hypertension (systolic blood pressure [BP]>160 mmHg or diastolic blood pressure>100 mmHg), if blood pressure can be controlled within the above limits by antihypertensive therapy, patients with a history of hypertension are allowed to be included in the study; 4. Past or current cancer, except for the following conditions: (1) Treated skin basal cell carcinoma or squamous cell carcinoma; (2) Any cancer that has been cured> 3 years before randomization; 5. For symptomatic brain or meningeal metastases, unless the patient has completed definitive treatment for more than 6 months, there is no evidence of tumor growth in the imaging examination, and the tumor is clinically stable at the time of randomization, and the patient cannot be receiving short-term steroids treatment or dose reduction (long-term steroid therapy is acceptable if the stable dose is treated for at least 1 month before and after the screening phase imaging study); 6. Known history of human immunodeficiency virus (HIV) infection; 7. Patients who are receiving or have received anti-cancer treatment within 4 weeks before randomization. For patients who have received previous anti-CTLA-4 treatment, if they have at least 5 half-lives (approximately 75 days) before randomization, they can be included in the study, cellular immunotherapies such as cancer vaccines and CIK are allowed, past radiotherapy is acceptable but the following conditions must be met: (1) Therapeutic radiotherapy is completed >=3 weeks before the baseline tumor scan; (2) Palliative radiotherapy for bone metastasis or soft tissue disease is allowed but should be completed> 7 days before the baseline tumor scan; (3) If the previous radiotherapy site is the only focus, there must be evidence of disease progression; Anti-cancer therapy is defined as any drug therapy or drug combination therapy with clinically proven anti-tumor activity. Any route of administration can be used for the purpose of directly or indirectly affecting malignant tumors (including palliative and therapeutic endpoints); 8. Substance abuse medical psychological or social conditions that may interfere with patients' participation in research or evaluation of research results; 9. Active infection ( >=CTCAE v.4.03 level 3) or active hepatitis B or C or active tuberculosis requiring treatment and the end of tuberculosis treatment within half a year; 10. Arterial or venous thrombosis or embolism such as cardio-cerebrovascular accidental deep vein thrombosis or pulmonary embolism (including transient ischemic attack) occurred within 3 months before randomization; 11. Past or current uncontrolled cardiovascular diseases include the following diseases: (1) Congestive heart failure (CHF) with NYHA> 2; (2) Unstable angina (with symptoms of angina at rest) or new angina in the 3 months before randomization; (3) Myocardial infarction (MI) was present 6 months before randomization; 12. Any previous treatment/surgery-related toxicity has not recovered to the National Cancer Institute's Common Terminology Standards for Adverse Events 4.03 (CTCAE v4.03) Grade 1 (excluding hair loss anemia and/or hypothyroidism); 13. Past immune diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSA remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Time to objective response;Time to PSA progression;Time to symptomatic skeletal event;Time to PSA response;Duration of PSA response;Radiologic progression-free survival time;Overall survival;The incidence, time and severity of treatment-emergent adverse event; | — |
Countries
China
Contacts
Public ContactZhou Fangjian
Cancer Center, Sun Yat-Sen University
Outcome results
None listed