Carrying out clinical trials of salbutamol hydrochloride combined with immunotherapy and castration for the treatment of prostate cancer is of great significance. Firstly, it can verify the efficacy and safety of this combination in the treatment of prostate cancer, providing a scientific basis for its clinical application. Secondly, through clinical trials, the mechanism of action of salbutamol hydrochloride combined with immunotherapy can be further studied. Finally, this clinical trial can further expand the treatment strategies for prostate cancer.
This study is a single-arm clinical trial. Eligible patients will be included in the group receiving farsufilide hydrochloride combined with immunotherapy. After enrollment, in addition to the routine androgen deprivation therapy, they will also receive farsufilide hydrochloride (10mg intravenous infusion) on days 1-5, and PD-1 monoclonal antibody (Tirapibep, 3mg/kg, intravenous infusion) on day 5. The treatment will be repeated every 21 days for a total of 4 times.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
This study is a single-arm clinical trial. Eligible patients will be included in the group receiving farsufilide hydrochloride combined with immunotherapy. After enrollment, in addition to the routine use of castration therapy, they will also receive farsufilide hydrochloride (10mg intravenous infusion) on days 1-5, and PD-1 monoclonal antibody (Tirapibep, 3mg/kg, intravenous infusion) on day 5. The treatment will be repeated every 21 days for a total of 4 times.
Zhongda Hospital
Nanjing, China
RECRUITINGPSA level
Before and after each cycle of treatment, blood samples were collected from the elbow vein on an empty stomach in the morning. The serum PSA level was detected using the enzyme-linked immunosorbent assay method.
Time frame: About 4 months
KPS scoring scale
On the 6th day after medication administration, a quality of life assessment was conducted for the patient, referring to the KPS scoring scale. The score range is from 0 to 100, with 0 indicating death and 100 indicating normal, without any symptoms or signs. The assessment focused on the changes in the patient's quality of life, with higher scores indicating better quality of life.
Time frame: About 4 months
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