NL-OMON46832撤回不适用
Ovarian cancer treatment with a liposome formulated mRNA Vaccine in combination with neo-adjuvant chemotherapy - OLIVIA
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 10
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
- 18 至 99（—）
入选标准
- •- Primary epithelial OC patients whom are treated with neoadjuvant
- •chemotherapy, carboplatin/paclitaxel, and subsequent surgery.
- •- Age * 18 years
- •- Signed informed consent in accordance with institutional and
- •regulatory guidelines
- •- Life expectancy * 5 months
- •- Adequate access of the tumor for image guided biopsy
- •- Adequate(according to the instiutional standards) hematology, liver
- •and kidney function to undergo chemotherapy with carboplatin and paclitaxel
排除标准
- •or any other systemic intercurrent disease or condition that might affect
- •the immunocompetence of the patient, or treatment with systemic highly
- •immunosuppressive therapy (e.g. transplant recipients or patients who
- •underwent a splenectomy)
- •- Use of systemic continuous corticosteroid therapy (e.g. prednisone i.v.
- •or p.o. > 7,5 mg / day).
- •- Neurological toxicity > grade 1 at screening
- •- History of a second malignancy except curatively treated low-stage
- •tumors with a histology that can be differentiated from the serous OC
- •- Pregnancy
- •- Participation in a trial with another investigational drug within 30 days
- •prior to the enrolment in this trial
- •- Any condition that in the opinion of the investigator could interfere
- •with the conduct of the trial.
研究者
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