Drug Screening of Patient-derived Organoids From Ovarian Cancer Culture to Personalized Therapy,an Exploratory Research
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
The tumor organoids platform can provide the precise genetic information and phenotype, as well as the heterogeneity of the tumor, thus provide information on drug sensitivity specific to the patient.This is an exploratory research to see if organoids testing could help guide precision treatment for ovarian cancer(OC) patients.
详细描述
Tissue will be received from operative specimens( primary ovarian carcinoma) at time of primary cytoreductive surgery.Ovarian cancer(OC) organoids will be then cultured. Organoids will be validated with a combination of Next Generation Sequencing (NGS) analysis and immunohistochemistry (TP53, PAX8 etc). After then, the patient-derived organoids cultured from OC will be compared the sensitivity to standard regimens (chemotherapies and targeted agents) recommendated by NCCN guidlines versus patients treated in clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ovarian cancer patients who will accept primary cytoreductive surgery, with histopathological type: low/high grade serous carcinoma, clear cell carcinoma, endometrioid carcinoma, mucinous carcinoma.
- •ECOG score 0~1,age 18~70 years old
- •Expected survival over 6 months
- •The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial
- •CBC：Hb≥70g/L、WBC≥3.5×109/ L 、ANC≥1.5×109/L、PLT≥80×109/L；
- •Serum ALT≤2×UL, AST≤2×ULN；Serum creatinine≤1.5×ULN；
排除标准
- •Activity or uncontrol severe infection
- •Liver cirrhosis, Decompensated liver disease
- •History of immune deficiency, including HIV positive or suffering from congenital immunodeficiency disease
- •Chronic renal insufficiency or renal failure
- •Has combined with other malignant tumor which diagnosed within 5 years and/or needed to be treated
- •Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure
- •During the treatment for complications, the drugs which lead to serious liver and/or kidney function impairment need to be used, such as tuberculosis
结局指标
主要结局
PFS
时间窗: 5 years
Progression-free survival
OS
时间窗: 5 years
Overall survival
次要结局
- DCR(1 year)
- ORR(1 year)
研究者
Dongling Zou
Director of Gynecologic Oncology Department
Chongqing University Cancer Hospital