Precision Medicine for Advanced or Recurrent Colorectal Cancer Directed by High-throughput Sequencing and Tumor Organoids Model
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Identification of effective drugs or drug combinations
研究概览
简要总结
Researchers collect specimens from advanced or recurrent colorectal cancer (CRC) patients to conduct molecular profiling and establish tumor organoids (PDOs)/ patient-derived xenografts (PDXs). The aim of this study is to identify clinical actionable targets and predict in vivo response of the tumor to targeted drugs by using PDOs/ PDXs. And the above-mentioned studies will provide the patients with potential personalized cancer treatment options.
详细描述
Patient-derived organoid is a model that can recapitulate the histology and behavior of the cancer from which it is derived, and is increasingly used as a tool for drug development in pre-clinical settings. Clinical treatment option of colorectal cancer now is quite limited. By molecular profiling, clinical actionable alterations may be identified. And according to the genomic investigation results, we can find the matched targeted drugs, following further testing in the organoids and PDXs. This will provide an opportunity to guide the precision medicine.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, age 18 to 75 years old
- •Patients with a documented (histologically- or cytologically-proven) advanced or recurrent colorectal cancer
- •Patients must have Eastern Cooperative Oncology Group (ECOG) performance status =< 1 and a life expectancy of at least 3 months
- •Patients, both male and female, who are either not of childbearing potential or who agree to use a medically effective method of contraception during the study and for 3 months after the last dose of study drug.
- •Patients with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol.
排除标准
- •Patients with any other life-threatening illness, significant organ system dysfunction, or clinically significant laboratory abnormality, which, in the opinion of the Investigator, would either compromise the patient's safety or interfere with evaluation of the safety of the study drug
- •Patients with abnormal coagulation function, bleeding tendency, or receiving thrombolytic or anticoagulant therapy
- •Patients with any other serious/active/uncontrolled infection, any infection requiring parenteral antibiotics, or unexplained fever > 38ºC within 2 weeks prior to first study drug administration.
- •Patients with a history of human immunodeficiency virus (HIV) or any other immunodeficiency disease.
- •Patients who are currently using certain drugs that are not permitted
- •Patients with a psychiatric disorder or altered mental status that would preclude understanding of the informed consent process and/or completion of the necessary studies
- •Patients with the inability, in the opinion of the Investigator, to comply with the protocol requirements
结局指标
主要结局
Identification of effective drugs or drug combinations
时间窗: up to 3 years
Viability of organoid is measured using CellTiter-Glo by quantifying ATP, which indicates the presence of metabolically active cells.
次要结局
- Correlation between organoid and PDX drug sensitivities(Up to 3 years)
- Comparison of clinical actionable alterations identified in native tumor and organoids.(Up to 3 years)
研究者
Zheng Wang, MD/PhD
Study chair, Clinical Professor
Wuhan Union Hospital, China