Drug Screening of Patient-derived Organoids From Advanced/Recurrent/Metastatic Colorectal 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
- Progression-free Survival
研究概览
简要总结
The study aims to establish an organoids platform and apply them to screen drugs for advanced/recurrent/metastatic colorectal cancer patients.
详细描述
The study was designed as a prospective, observational clinical trial in a single center. We establish organoids derived from patients with advanced/recurrent/metastatic colorectal cancer. Organoids will be validated with a combination of Next Generation Sequencing (NGS) analysis and histopathology. Drug screening assay will be performed on organoids with the chemotherapy and targeted agents, and the sensitivity and speciality will be compared with the 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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients voluntarily participated in the study and signed informed consent;
- •ECOG score 0~2;
- •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；
- •Colorectal cancer was unresectable and confirmed as adenocarcinoma by histopathology. Patients have no significant symptoms in the primary lesion (no bleeding, perforation and obstruction in the primary focus). Besides, the carcinoma is potentially resectable but the patient refuses surgery;
- •Patients can comply with the research scheme according to the judgment of the researcher.
排除标准
- •Activity or uncontrol severe infection;
- •Liver cirrhosis, Decompensated liver disease;
- •History of immune deficiency, including HIV positive or suffering from a congenital immunodeficiency disease;
- •Chronic renal insufficiency or renal failure;
- •Other malignancies which diagnosed within 5 years or needed to be treated;
- •Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure
- •Concomitant diseases are treated by drugs that impair liver or kidney function, such as tuberculosis.
结局指标
主要结局
Progression-free Survival
时间窗: 2 years
Progression-free survival means the duration from enrollment to disease progression or death
Overall Survival
时间窗: 3 years and 5 years
Overall survival means the duration from enrollment to death due to any cause. The last follow-up time is calculated as the death time for subjects who lost follow-up
次要结局
- Diagnostic Indicators(2 years)
研究者
Dongling Zou
Director of Gynecologic Oncology Department
Chongqing University Cancer Hospital