NCT02107950已完成2 期
A Randomized, Open-label, Parallel Group, Multi-center Phase II Clinical Trial DCVAC/OvCa Added to Standard Chemotherapy in Women With Relapsed Platinum Sensitive Epithelial Ovarian Carcinoma
SOTIO a.s.0 个研究点目标入组 71 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 主要终点
- Determine median progression free survival
研究概览
简要总结
The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy (carboplatin and gemcitabine as second line chemotherapy) may result in prolongation of progression free survival (PFS).
详细描述
The purpose of this study is to determine whether DCVAC/OvCa added to Standard of Care chemotherapy (carboplatin and gemcitabine as second line chemotherapy) may result in prolongation of progression free survival (PFS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Females 18 years old and older
- •Patients with histologically confirmed, International Federation of Gynecology and Obstetrics (FIGO) stage III or IV epithelial ovarian, primary peritoneal or fallopian tube carcinoma (serous, endometrioid or mucinous), who had complete remission after first line platinum (Pt)-based chemotherapy and are selected to receive second line Standard of Care chemotherapy
- •Radiologically confirmed relapse after >6 months of remission (Platinum-sensitive patients), found up to 4 weeks prior study entry.
- •The patient must have at least one measureable target lesion as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria to be eligible for enrolment in the study
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 [for example chemotherapy, monoclonal antibody therapy , tyrosine kinase inhibitor therapy, vascular endothelial growth factor (VEGF) therapy or hormonal therapy] except first line Platinum-based chemotherapy (with or without bevacizumab)
- •Previous radiotherapy to the abdomen and pelvis
- •Malignancy other than epithelial ovarian cancer, except those that have been in clinical remission (CR) for a minimum of 3 years, and except carcinoma in-situ of the cervix or non-melanoma skin carcinomas
研究组 & 干预措施
DCVAC/OvCa in parallel with chemotherapy
Experimental
Combination therapy with DCVAC/OvCa and Standard of Care
干预措施: DCVAC/OvCa in parallel with chemotherapy (Biological)
Standard of Care
Active Comparator
Standard of Care carboplatin and gemcitabine
干预措施: Standard of Care (Drug)
结局指标
主要结局
Determine median progression free survival
时间窗: 72 Week
次要结局
- Immunological Response(24, 48, 72 weeks)
- Frequency of adverse events(8, 16, 24, 32, 40, 48, 56. 64. 72 weeks)
- Overall survival (all causes)(56, 64, 72 weeks)
- Objective Response Rate(8, 16, 24, 32, 40, 48, 56. 64. 72 weeks)
- Biological Progression Free Interval(6, 12, 18, 24, 36, 42, 48, 56, 64, 72 weeks)
研究者
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