A Real-world Study of Clinical Markers for PARP Inhibitors in Epithelial Ovarian Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
Epithelial ovarian cancer (EOC) is the most lethal gynecological malignancy. PARP inhibitors(PARPi) are an important progress in EOC treatment. The available evidence suggests that BRCAmt or HRD-positive is an effective biological marker for PARPi. However, in our previous clinical observation, it was found that the tumor burden may be the potential clinical markers PARPi. We intend to develop a real-world study to confirm the potential clinical markers and explore new clinical markers for PARPi.
详细描述
This study intends to conduct a systematic real-world study to observe the relationship between the clinical characteristics of EOC patients and the efficacy of PARPi based on our existing research foundation and stratified analyse these correlations by BRCA and HRD status.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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 should test for BRCA gene and will perform test for HRD status if who harbor BRCAwt in the same laboratory designated by the researcher;
- •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 cancer patients treated with PARP inhibitors
PARP inhibitors therapy until disease progression
干预措施: PARP inhibitors (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.
Duration of Response (DOR)
时间窗: Through study completion, an average of 1 year
DOR is defined as the time from the first date of response until the date of first documented progression.
Disease Control Rate (DCR)
时间窗: Through study completion, an average of 1 year
DCR is defined as the proportion of participants achieving complete response (CR), partial response (PR) or stable disease (SD) according to RECIST1.1.
Adverse events (AEs)
时间窗: Through study completion, an average of 1 year
Number of participants with treatment-related adverse events as assessed by CTCAE 5.0 to further describe safety and assess toxicities encountered with the use of the proposed treatment regimen in participants.
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