Dendritic Cell Vaccination for the Adult Ovarian Cancer
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- adverse events
研究概览
简要总结
Effective treatments are desperately needed for ovarian cancer patients. This phase I clinical trial assesses the safety of a novel personalized dendritic-cell vaccine administered to ovarian cancer patients. Secondary outcomes will be evaluated such as patient pharmacodynamics， progression-free survival and overall survival.
详细描述
This is a single arm, non-randomized phase I study to evaluate the safety and feasibility of delivering a novel dendritic cell vaccine in 6 to 12 (n=6-12) adult patients diagnosed with ovarian cancer after undergoing surgical resection. The vaccine contains both tumor-associated antigen and patient specific neoantigens. Standard-of-care chemotherapy therapy will be followed as per routine,during which patients enrolled into this study will receive a personalized vaccine in addition to standard of care. Effective adjuvant therapies are urgently needed for these patients given that high rate of recurrence still occurs after standard of care with poor prognosis among ovarian cancer patients. The study is constructed in a 3+3 algorithm for two steps of dose escalation with rigorous and mandatory safety monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •18-75 years old female patients；
- •Histopathologically diagnosed recurrent stage III/IV epithelial ovarian cancer;
- •Normal liver, heart as well as kidney functions and blood chemistry;
- •Predicted survival for more than 6 months；
- •Provision of signed and dated informed consent form.
排除标准
- •Allergic to human albumin, an excipient of the manufactured dendric cell vaccine；
- •Predicted survival for less than 6 months；
- •Diagnosed with brain metastasis and other diseases unsuitable for cell therapy including but not limited to Myelodysplastic Syndromes、Acute Myeloid Leukemia and Systemic Lupus Erythematosus;
- •Diagnosed with viral diseases including but not limited to HIV, TP, HCV and HBV ；
- •Female patients who are pregnant, breast feeding, or of childbearing potential without a negative pregnancy test prior to baseline;
- •Other conditions deemed unsuitable for this study by the leading investigators.
结局指标
主要结局
adverse events
时间窗: up to 18 months
Patients will be monitored for adverse events as dictated by CTCAE version 5.
次要结局
- PFS(up to 18 months)
- Pharmacodynamics(up to 1 week)
- OS(up to 18 months)
研究者
Rutie Yin
Clinical Professor
West China Second University Hospital