prostate cancer
Conditions
Interventions
Experimental group:PD-1 antibody combined with radiation therapy
Sponsors
Department of Abdominal Oncology, West China Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients with prostate cancer confirmed by histopathology and/or cytology (including postoperative recurrence and metastasis) without neuroendocrine differentiation or small cell features. The disease should be metastatic or local advanced and inoperable, without curative purpose; 2. Patients who failed ADT therapy combined with at least one novel endocrine therapy therapy, or failed ADT therapy followed by at least one novel endocrine therapy; 3. Patients at hormone-sensitive prostate cancer (HSPC) stage who have not received ADT combined with docetaxel regimen, patients who need to receive or unable to tolerate or refuse docetaxel regimen chemotherapy after diagnosis of CRPC stage; 4. For mCRPC patients with DNA-HRR gene mutation who had not received PARP inhibitor therapy, they refused PARP inhibitor therapy or had contraindication to PARP inhibitor therapy; 5. Patients were recorded with disease progression (disease progression was defined as one or more of the following 3 events) in the 6 months prior to enrolment: (1)PSA progression: increased PSA levels were measured at least 3 times with an interval of >=1 week, and the PSA value should be >= 2 ng/mL each time; (2) For patients without PSA progression, imaging (RECIST 1.1) assessed the presence of soft tissue or bone metastatic lesion progression; (3) PCWG2-defined progression of bone lesions, i.e., 2 or more new lesions found on bone scan. 6. Patients with clinical evidence of distant metastatic disease (bone scan, CT/MRI); 7. For patients currently on continuous ADT therapy, serum total testosterone is required 6 months; 10. Patients with sufficient organ and bone marrow function. Laboratory tests meet the following criteria: (1) Routine blood test: hemoglobin (Hb) >= 90g/L (no blood transfusion within 14 days); Neutrophils absolute value (ANC) >=1.5x10^9/L; Platelet (PLT) >= 100 x 10^9/L; (2) Biochemical tests: serum creatinine (CR) =60 mL/min when serum creatinine > 1.5x upper limit of normal (ULN) of subjects; Bilirubin Bil <=1.5xULN; ALT and AST <=2.5xULN (subjects with liver metastasis <= 5 x ULN); (3) Coagulation function: the international standardized ratio (INR) < 1.5. 11. Reproductive men must agree to use an appropriate method of contraception for a period of 120 days from the first study drug to the last study drug.
Exclusion criteria
Exclusion criteria: 1 Before inclusion, patients with the toxicity of the original treatment regimen had not recovered, and there were still toxicity reactions above grade 1; 2. Patients who participated in clinical trials of other drugs within 1 month; 3 Patients have been diagnosed with immunodeficiency or are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first medication; 4. Patients have used or is using a FAK inhibitor or anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-cytotoxic T lymphocyte associated antigen 4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug targeting the T cell co-stimulatory or checkpoint pathway) within 4 weeks prior to first administration; 5. Patients with a history of other malignant tumors (basal cell carcinoma of the skin, except orthotopic cervical cancer) within 5 years; 6. Patients with known or suspected new BMs: Subjects with signs or symptoms suggestive of BMs will not be allowed to participate in the study unless BMs have been ruled out by CT or MRI.However, subjects with controlled BMS (no radioactivity progression for at least 4 weeks after radiotherapy and/or no neurological symptoms or signs after surgical resection) could be enrolled; 7. Patients with an active autoimmune disease requiring systemic treatment (e.g., use of disease modifiers, corticosteroids, or immunosuppressive drugs) has been present in the past 2 years; 8. Patients with interstitial pulmonary disease and/or present (non-infectious) pneumonia requiring continued steroid therapy; 9. Patients with combined active infection requiring systemic treatment; 10. Patients with a previous history of epilepsy or taking drugs that cause epilepsy or with a history of severe central nervous system diseases; 11. Patients with severe cardiovascular disease, previous myocardial infarction or arterial thrombosis, unstable angina pectoris, or heart failure with clinical symptoms in the past 6 months; 12. Patients with serious, uncontrolled medical disorders or active infections that may impair the subject's ability to receive treatment as prescribed in the protocol, including but not limited to HIV positive, active tuberculosis; 13. Researchers consider the patients inappropriate to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate;safety; | — |
Countries
China
Contacts
Public ContactLi Zhiping
Department of Abdominal Oncology, West China Hospital, Sichuan University
Outcome results
None listed