NCT04869488已完成2 期
An Open, Multi-center, Phase Ⅱ Clinical Study of Fluzoparib Combined With Apatinib or Fluzoparib in the Treatment of Metastatic Castration-resistant Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Comprehensive response rate
研究概览
简要总结
Main research purpose: To evaluate the effectiveness of Fluzoparib combined with apatinib mesylate in the treatment of patients with metastatic castration-resistant prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Voluntary participation and written informed consent;
- •Age ≥18 years old;
- •Pathologically diagnosed metastatic castration-resistant prostate adenocarcinoma;
- •It is confirmed by the central laboratory based on tumor tissue or ctDNA detection that it is accompanied by germline or system homologous recombination repair-related gene mutations (Cohorts 4) or not accompanied by homologous recombination repair-related gene mutations (Cohort 2);
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- •Has a life expectancy of ≥ 12 weeks.
排除标准
- •Past (within 5 years) or concurrently suffering from other malignant tumors, except for cured skin basal cell carcinoma;
- •Subjects have used PARP inhibitors in the past, including but not limited to olaparib, niraparib, and lukapanib; or have used apatinib in the past; or have received mitoxantrone and cyclophosphamide in the past Treatment with amide or platinum-containing chemotherapeutics;
- •Severe bone injury caused by tumor bone metastasis, pathological fractures or spinal cord compression in important parts that occurred within 6 months before being informed or is expected to occur in the near future;
- •The subject has cancerous meningitis, or untreated central nervous system metastasis;
- •Those who cannot swallow pills normally, or have abnormal gastrointestinal function, which may affect drug absorption by the researcher;
- •Subjects with congenital or acquired immune deficiencies (such as HIV infection), or active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA ≥500 IU/ml; hepatitis C reference: HCV antibody positive and HCV virus copy number> upper limit of normal );
- •According to the judgment of the investigator, the subject has other factors that may cause the study to be terminated halfway, such as other serious diseases (including mental illness) that require combined treatment, severe laboratory abnormalities, family or society, etc. Factors that will affect the safety of subjects or the collection of data and samples.
研究组 & 干预措施
Fluzoparib
Experimental
干预措施: Fluzoparib (Drug)
Enzalutamide OR abiraterone acetate With Prednisone Acetate Tablets
Active Comparator
干预措施: Enzalutamide OR abiraterone acetate With Prednisone Acetate Tablets (Drug)
Fluzoparib Combined With Apatinib
Experimental
干预措施: Fluzoparib Combined With Apatinib (Drug)
结局指标
主要结局
Comprehensive response rate
时间窗: up to 2 years
Comprehensive remission rate means the proportion of objective remission or PSA remission evaluated by the investigator based on the RECIST v1.1 standard and the PCWG3 standard
次要结局
- Objective response rate (ORR)(At the time point of every 8 weeks，up to 2 years)
- PSA response rate(At the time point of every 4 weeks，up to 2 years)
- Time to PSA progression (PSA-TTP)(At the time point of every 4 weeks，up to 2 years)
- Overall Survival (OS)(At the time point of every 2 months，up to 2 years)
- Radiological progression-free survival (rPFS)(up to 2 years)
研究者
研究点 (1)
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