A Clinical Study on the Efficacy and Safety of Fasudil Hydrochloride Combined With Immunotherapy in the Treatment of Metastatic Castration-resistant Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- PSA level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and < 85 years;
- •Patients who have failed at least one chemotherapy regimen containing docetaxel and one standard novel endocrine therapy;
- •Diagnosed with CRPC, defined as: after continuous castration therapy, the castration level of testosterone is < 50 ng/ml; disease progression within 12 weeks before enrollment: PSA levels increase consecutively for 3 times at intervals of 1 week, and serum PSA ≥ 2 ng/ml; evaluated as soft tissue progression according to RECIST criteria, or ≥ 2 new lesions on bone scan;
- •Imaging evidence indicates bone metastatic disease and/or measurable non-bone metastatic disease (lymph nodes or internal organs); Expected survival period ≥ 3 months; All patients voluntarily signed the informed consent form and were able to cooperate with treatment and follow-up;
排除标准
- •Severe cardiovascular and cerebrovascular diseases;
- •Abnormal liver function: Total bilirubin in blood is less than 1.5 times the upper limit of normal value, and the ratio of blood ALT to AST is less than 2 times the upper limit of normal value;
- •Abnormal kidney function: Serum creatinine is less than 1.5 mg/dl or the creatinine clearance rate is greater than or equal to 60 cc/min;
- •Those allergic to the used drugs;
- •Those with tumors in other parts;
- •Abnormal thyroid function: Blood FT4 and/or TT4 levels are higher or lower than the normal value (normal blood FT4 level is 9-25 pmol/L (0.7-1.9 ng/dl), normal blood TT4 level is 64-154 nmol/L (5-12 ug/dl));
- •Cortisol deficiency: Serum cortisol at 8 a.m. is less than 140 nmol/L (5 ug/dL).
研究组 & 干预措施
The group treated with farsulide hydrochloride combined with immunotherapy
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.
干预措施: Fasudil hydrochloride combined with immunotherapy (Drug)
结局指标
主要结局
PSA level
时间窗: About 4 months
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.
次要结局
- KPS scoring scale(About 4 months)
研究者
baotai Liang
resident doctor
Zhongda Hospital