EUCTR2017-002196-26-CZ进行中（未招募）1 期
An open-label, single-group, multicenter phase II clinical trial evaluating the effect of maintenance DCVAC/OvCa after standard of care therapy in women with first relapse of platinum-sensitive epithelial ovarian carcinoma
SOTIO a.s.0 个研究点目标入组 30 人开始时间: 2017年7月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •- Female aged =18 years
- •- Patients with histologically confirmed FIGO stage III and IV epithelial ovarian, primary peritoneal, or fallopian tube carcinoma
- •- Radiologically confirmed relapse after >6 months of remission
- •- Laboratory parameters per protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •- FIGO I, II epithelial ovarian cancer
- •- FIGO III, IV clear cells epithelial ovarian cancer
- •- Non-epithelial ovarian cancer
- •- Borderline tumors (tumors of low malignant potential)
- •- Prior or current systemic anti-cancer therapy for ovarian cancer except first line Pt based chemotherapy (with or without bevacizumab)
- •- Pre-defined co-morbidities
- •- Known hypersensitivity to any constituent of DCVAC/OvCa or the selected chemotherapy compounds
- •- Fertile woman of childbearing potential not willing to use a highly effective method of contraception or combination of methods
- •- Pregnant or lactating women
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