Homologous Recombination Deficiency Associated With Response to Poly (ADP-ribose) Polymerase Inhibitors in Ovarian Cancer Patients: the First Real-word Evidence From China
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
Homologous recombination deficiency (HRD) is an important molecular biomarker for Poly (ADP-ribose) polymerase inhibitors (PARPi) which is a significant progress in the treatment of ovarian cancer. However, the proportion of HRD positive in real world and relationship of HRD status with PARPi in Chinese ovarian cancer patients remains unknown.
详细描述
This study intends to perform HRD testing of ovarian cancer in real world from China and correlate HRD status and clinical characteristics with therapeutic outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Subjects join the study voluntarily and sign informed consent;
- •Female subjects are older than 18 years;
- •ECOG(Eastern Cooperative Oncology Group) physical status score is 0-2;
- •Life expectancy≥3 months;
- •Histologically confirmed FIGO(International Federation of Gynecology and Obstetrics ) III/IV ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; Participants must have high-grade serous or endometrioid histology;
- •Patients received PARP inhibitor as maintenance therapy or monotherapy for more than four weeks.
排除标准
- •Personnel involved in the formulation or implementation of the research plan;
- •Patient participated in other clinical trails using other experimental drugs at the same time as the study;
- •The subjects had other malignant diseases in past 2 years, except skin squamous cell carcinoma, basal-like carcinoma, breast intraductal carcinoma in situ, or cervical carcinoma in situ;
- •Previous or currently diagnosed myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
- •Patients who are pregnant or lactation, or who plan to become pregnant during study treatment.
研究组 & 干预措施
ovarian/fallopian tube/primary peritoneal cancer patients
ovarian/fallopian tube/primary peritoneal cancer patients treated with PAPRi for more than four weeks
干预措施: PARP inhibitor (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: Through study completion, an average of 1 year
ORR is defined as the proportion of participants achieving complete response (CR) or partial response (PR) as assessed by RECIST1.1.
Progression Free Survival (PFS)
时间窗: Through study completion, an average of 1 year
PFS is defined as the time in months from the date of first study drug administration to the date of first documentation of progressive disease (PD) or death as assessed by RECIST1.1.
次要结局
未报告次要终点
研究者
Xiaoxiang Chen
Academic secretary of gynecological oncology Committee of Jiangsu anti cancer association
Jiangsu Cancer Institute & Hospital