NCT07472140招募中2 期
To Develop and Implement The Scope of Medical Care for Homologous Recombination Deficient Ovarian Cancer, Fallopian-Tube Cancer, or Primary Peritoneal Cancer of the III-IV Stages Using Maintenance Therapy With PARP Inhibitor Combined With Angiogenesis Inhibitor.
N.N. Alexandrov National Cancer Centre1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
This is a randomized trial evaluating the results of using of PARP inhibitor combined with angiogenesis inhibitor. in patients with homologous recombination deficient primary ovarian cancer, fallopian-tube cancer, or primary peritoneal cancer of the III-IV stages.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥18-≤75 years.
- •Histologically confirmed diagnosis of serous or endometrioid high-grade ovarian cancer, fallopian-tube cancer or primary peritoneal cancer.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Possibility of performing diagnostic laparoscopy or cytoreductive surgery.
- •Presence of homologous recombination deficiency (HRD).
- •No contraindications to chemotherapy, or bevacizumab.
- •Signed informed consent to participate in the study.
排除标准
- •Presence of another active malignant invasive neoplasm.
- •Pregnancy or lactation period.
- •Disease progression during treatment.
研究组 & 干预措施
PARPi
Experimental
干预措施: PARP inhibitor (Drug)
PARPi + Bev
Experimental
干预措施: PARP inhibitor + Bevacizumab (Drug)
结局指标
主要结局
Disease-free survival
时间窗: From enrollment through study completion, an average of 2 year
Time from randomization to any sign or symptom of the cancer or death from the disease
The frequency of adverse events
时间窗: From date of first immunotherapy dose through 60 months, or date of last patient contact
次要结局
- Time from Randomization to First Subsequent Therapy(From enrollment through study completion, an average of 2 year)
- Disease-free survival 2(From the first recurrence through study completion, an average of 2 year)
- The quality of life(Through study completion, an average of 5 year)
研究者
研究点 (1)
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