NCT06552858尚未招募2 期
Fluzoparib Combined With Dalpiciclib for Platinum Resistant Recurrent Ovarian Cancer: a Phase II Clinical Study
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
- 30
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
This study aims to investigate the safety and efficacy of combination therapy of Fluzoparib combined With Dalpiciclib for platinum-resistant recurrent ovarian cancer through a single-center, prospective, single-arm, phase II clinical trial, to improve the overall treatment level and prognosis of platinum-resistant ovarian cancer.
详细描述
- Overall Design: This trial is a single-center, prospective, single-arm, phase II clinical trial to evaluate the safety and efficacy of combination therapy of Fluzoparib combined With Dalpiciclib for platinum-resistant recurrent ovarian cancer.
- Experimental observation indicators: 1) Main indicators: progression-free survival (PFS), 2) Other indicators: overall survival (OS), objective response rate (ORR), and adverse reactions.
- Sample size calculation: The median PFS of platinum-resistant recurrent ovarian cancer patients is 3.8 months. In comparison, the experimental group is expected to have a median PFS of 7 months, with an alpha value of 0.05. Following up for 1 year and considering a 10% dropout rate, this study plans to include 30 platinum-resistant recurrent ovarian cancer patients.
- Data Processing: Enter data and use SPSS statistical software for statistical analysis. Statistical analyst: Clinical Statistics Department of Fudan University Cancer Hospital. Mailing address: 270 Dong'an Road, Shanghai.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age≥18 years old;
- •Sign the informed consent form;
- •Histologically-confirmed epithelial ovarian or fallopian-tube cancer or primary peritoneal cancer.
- •Tumor recurrence or progression within 6 months after using platinum-based drugs;
排除标准
- •Any uncontrolled medical condition that may put the patient at high risk during treatment .
- •Receipt of any other investigational medicinal product within the last 30 days before randomization.
- •Patients with ovarian cancer excluded by pathological or clinical diagnosis;
- •Physical intolerance patients;
- •Patients who are unwilling to participate in the clinical trial.
研究组 & 干预措施
Fluzoparib with Dalpiciclib
Experimental
Oral administration of Fluzoparib with Dalpiciclib until disease progression or toxicity intolerance.
干预措施: Fluzoparib (Drug)
Fluzoparib with Dalpiciclib
Experimental
Oral administration of Fluzoparib with Dalpiciclib until disease progression or toxicity intolerance.
干预措施: Dalpiciclib (Drug)
结局指标
主要结局
PFS
时间窗: Two years
Progression free survival
次要结局
- OS(Two years)
- ORR(Two years)
研究者
Xiaohua Wu MD [zzhong]
Director of Gynecological Oncology
Fudan University
研究点 (1)
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