JPRN-jRCT2080224597已完成3 期
ATHENA (A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy)
Clovis Oncology,Inc./ CMIC Co., Ltd.0 个研究点目标入组 100 人开始时间: 2019年3月15日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- Female
入选标准
- •1. Have newly diagnosed, advanced (FIGO stage III-IV),high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- •2. Completed cytoreductive surgery, including at least a bilateral salpingo-oophorectomy and partial omentectomy, either prior to chemotherapy (primary surgery) or following neoadjuvant chemotherapy (interval debulking).
- •3. Completed first-line platinum-based chemotherapy and surgery with a response, in the opinion of the Investigator.
- •4. Have sufficient tumor tissue for planned analyses.
- •5. Have an ECOG performance status of 0 to 1.
排除标准
- •1.Pure sarcomas or borderline tumors or mucinous tumors.
- •2.Active second malignancy
- •3.Known central nervous system brain metastases.
- •4.Any prior treatment for ovarian cancer, other than the first-line platinum regimen,
- •5.Evidence of interstitial lung disease, active pneumonitis,
- •6.Active, known or suspected autoimmune disease
- •7.Condition requiring active systemic treatment with either corticosteroids (more than 10 mg daily prednisone equivalent) or other immunosuppressive medications
研究者
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