A Comparative Study of the Treatment of Real-world Patients With Clear Cell Carcinoma of the Ovary
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- tumor response rate
研究概览
简要总结
The goal of this observational study is to learn about the treatment effectiveness of physician's choice of chemotherapy and the immune checkpoint inhibitor (ICI)-based therapy in patients with relapsed/refractory ovarian clear cell carcinoma (OCCC), and compare the treatment response with the phase II, single-arm clinical trial INOVA to investigate the efficacy of combinational therapy of sintilimab plus bevacizumab. The main questions it aims to answer are:
- What is the efficacy of physician's choice of chemotherapy in relapsed/refractory OCCC patients in the real world?
- Is ICI-based therapy more effective than physician's choice of chemotherapy in real-world for relapsed/refractory OCCC patients?
- Dose the combinational regimens of sintilimab plus bevacizumab in Sintilimab Plus Bevacizumab in Recurrent/Persistent Ovarian Clear Cell Carcinoma (INOVA) trial more effective than physician's choice of chemotherapy?
Participants will be respectively retrieved and extracted de-identified, longitudinal electronic health records (EHR)-derived data.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Female patients with age ≥ 18 years old and ≤ 75 years old.
- •There must be a histological diagnosis of ovarian clear cell carcinoma.
- •Patients with recurrent or persistent ovarian clear cell carcinoma must have at least one-line pretreated platinum-containing chemotherapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status score ≤
- •Expected survival time ≥ 12 weeks.
排除标准
- •1.Histological evidence of non-ovarian clear cell carcinoma.
研究组 & 干预措施
real-world study (RWS)-Chemotherapy
干预措施: physician's choice of chemotherapy (Drug)
RWS-ICI
干预措施: immune checkpoint inhibitor based therapy (Drug)
结局指标
主要结局
tumor response rate
时间窗: through study completion, an average of 1 year
The tumor responses to treatment were evaluated by an independent central investigator according to RECIST version 1.1
次要结局
- progression-free survival (PFS)(through study completion, an average of 1 year)
- time to response (TTR)(through study completion, an average of 3 months)
- duration of response (DOR)(through study completion, an average of 1 year)
- disease control rate (DCR)(through study completion, an average of 1 year)