NCT05819060尚未招募2 期
The Efficacy and Safety of The Fuzuloparib Combination With Bevacizumab in Maintenance Treatment for Platinum-Sensitive Recurrent Ovarian Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
The study will be a Prospective, Single-arm, Phase Ⅱ Clinical Study. This study intends to explore the efficacy and safety of Fuzuloparib combined with bevacizumab in the maintenance treatment of patients with platinum-sensitive ovarian cancer. The progression-free survival, OS, and safety were evaluated based on RECIST V1.1.
详细描述
Due to the lack of effective predictive molecular markers in the maintenance treatment phase, it is difficult to assess the effectiveness of maintenance treatment. This project plans to collect blood and urine from subjects before maintenance treatment, during relapse, and for follow-up molecular marker exploration research.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with platinum-sensitive recurrent ovarian cancer confirmed by pathology or histology;
- •Patients who have previously received platinum-based chemotherapy and had a recurrence interval of > 6 months before the last platinum-based chemotherapy;
- •Patients who have previously received bevacizumab and did not experience progression within 3 months during the use of bevacizumab;
- •Patients who have previously received PARP inhibitors and did not experience progression within 12 months during the use of PARP inhibitors;
- •The patient achieved a complete or partial response after the last platinum-based chemotherapy;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- •The patient has a life expectancy of at least 3 months and sufficient organ function;
- •The patient has sufficient bone marrow reserves and organ function, including a creatinine clearance rate of 45 mL/min calculated using the standard Cockcroft and Gault formula;
- •The patient voluntarily agrees to participate in this study and signs an informed consent form.
排除标准
- •Patients who are known to be allergic or intolerant to chemotherapy drugs or their excipients and cannot swallow medication;
- •Patients who have undergone major surgery within 28 days prior to enrollment;
- •Patients with central nervous system metastases or a history of seizures within the past 12 months;
- •Uncontrolled hypertension: systolic blood pressure ≥180mmHg, diastolic blood pressure ≥90mmHg;
- •NYHA functional class ≥ III;
- •Patients with severe, uncontrolled systemic diseases;
- •Patients who have received any other investigational drug treatment or participated in any other clinical trials within 30 days prior to enrollment in this study;
- •Pregnant or lactating patients, or patients who cannot guarantee effective contraception during the study treatment period;
- •Patients with poorly controlled neurological or psychiatric disorders or mental illness, poor compliance, and inability to cooperate or describe treatment response;
- •Patients judged by the investigator to be unsuitable for participation in this study.
研究组 & 干预措施
Fuzuloparib Combination with Bevacizumab
Experimental
Fuzuloparib 150mg/bid ; Bevacizumab 7.5mg/kg，d1，Q3W
干预措施: Fuzuloparib Combination with Bevacizumab (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: approximately 1.5 years
according to RECIST v1.1
次要结局
- Overall survival (OS)(Up to approximately 1.5 years)
- Adverse Events (AEs)(From the first drug administration to within 30 days for the last treatment dose])
研究者
Zhong Zheng MD
Professor, Director of Gynecologic Oncology
Fudan University
研究点 (1)
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