Next pErsonalized Cancer tX With mulTi-omics and Preclinical Model: The Master Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 895
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
The next generation of personalized medical treatment according to the type of personal genetic information are evolving rapidly. The genome analysis needs systematic infra and database based on personal genetic information Therefore, a big data of genome-clinical information is important.
To determine the feasibility of the use of tumor's molecular profiling and targeted therapies in the treatment of advanced cancer and to determine the clinical outcome(PFS, duration of response and overall survival) of patients with advanced cancer, the investigators are going to take a fresh tissue of patients and process molecular profiling and receive molecular profile directed treatments.
详细描述
This study nickname is NEXT-1 trial(Next pErsonalized cancer tX with mulTi). A single-center, open label trial to analysis of genetic information in advanced cancer.
If the target is to be confirmed by molecular profile, the subgroup is going to Umbrella trial type.
defined below: NEXT 1 trial is screening and feasibility -> NEXT trial is BASKET/umbrella study screening protocol(Molecular screening prolongs survival)->NEXT-1.1(gastric cancer),NEXT-1.2(colorectal cancer),NEXT-1.3(biliary tract cancer/pancreatic cancer),NEXT-1.4(Rare cancer),NEXT-1.5(genitourinary cancer)
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathologically confirmed metastatic malignancy
- •Written informed consent
排除标准
- •patients who do not agree with biopsy
- •patients who do not have enough tissue for acquisition
结局指标
主要结局
Response rate
时间窗: expected average of 3 years
To compare response rate (RR) (per RECIST 1.1) in patient cohort with molecularly matched treatment (in practice or in the context of clinical trials) versus RR in patient cohort with non-matched treatment based on molecular profiling
次要结局
- Progression Free Survival(expected average of 3 years)
- feasibility(expected average of 3 years)
研究者
Jeeyun Lee
MD,PhD
Samsung Medical Center