The Effect of Individualized Precision Therapy Programs in Patients With Biliary Tract Cancer
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This is a prospective cohort study. Patients who meet the inclusion criteria will be enrolled in this study. The samples of biliary tract tumors will be collected. Genome sequencing, mini-PDX and PDX will be performed according to the requirement of individualized precision therapy programs. Suitable drugs will be chose according to drug screening results. OS and PFS will be compared with traditional chemotherapy to evaluate the effect of individualized precision therapy programs.
详细描述
In this prospective cohort study, patients who are eligible for inclusion criteria will enroll in the study. After bile duct tumor samples were collected, whole genome sequencing, drug screening ( including Mini-PDX and PDX) will conduct. Suitable drugs will be decided according to the different genomics classification, and then to develop individualized precise treatment programs.
The investigators hope to achieve the following objectives:
① Through the establishment of Individualized Precision Therapy Programs to improve the overall survival of bile duct malignancy (BTC)；
② To study the molecular typing of the prognosis of biliary malignancy;
③ To construct a database of BTC gene bank, as well as for drug screening information.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathological diagnosis of biliary malignancies
- •The expected survival time is longer than 3 months
- •PKS score> 60 points
- •Willing to take part in the study
排除标准
- •Can not or refuse to collect tumor samples
- •Refused to accept the relevant treatment method
研究组 & 干预措施
IPTP Group
The IPTP Group will receive the Individualized Precision Therapy Programs. After bile duct tumor samples were collected, whole genome sequencing, drug screening ( including Mini-PDX and PDX) will conduct. Suitable drugs will be decided according to the different genomics classification.OS and PFS will be recorded.
干预措施: Individualized Precision Therapy Programs (Other)
结局指标
主要结局
Overall Survival (OS)
时间窗: through study completion, an average of 2 year
The time from surgery to all-cause death
次要结局
- Progression-Free Survival (PFS)(through study completion, an average of 2 year)