Validation of Organoids Potential Use as a Companion Diagnostic in Predicting Neoadjuvant Chemoradiation Sensitivity in Locally Advanced Rectal Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Response of the rectal cancer organoids to irradiation and the same chemotherapy drugs as the corresponding patient.
研究概览
简要总结
Patients with locally advanced rectal cancer will receive biopsy before the standard treatment of neoadjuvant chemoradiation. The investigators are going to establish organoids model from the pre-treatment biopsies and expose organoids to irradiation and the same chemotherapy drugs. The sensitivity of irradiation and chemotherapy drugs will be tested in the organoids model. Here, the investigators will launch the observational clinical trial to validate whether the organoids could predict the clinical outcome in locally advanced rectal cancer patients underwent neoadjuvant chemoradiation.
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
- •pathological confirmed adenocarcinoma
- •clinical stage T3-4 and/or N+
- •the distance from anal verge less than 12 cm
- •without distance metastases
- •KPS >=70
- •without previous anti-cancer therapy
- •sign the inform consent
排除标准
- •pregnancy or breast-feeding women
- •serious medical illness
- •baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
结局指标
主要结局
Response of the rectal cancer organoids to irradiation and the same chemotherapy drugs as the corresponding patient.
时间窗: 2018.08-2020.11
The investigators will culture rectal cancer organoids and treat with irradiation and the same chemotherapy drugs as the corresponding patient. The number and size of alive organoids will be observed after treatment. The correlation of organoids sensitivity and patient response will be evaluated.
次要结局
- Response of the rectal cancer patients to neoadjuvant chemoradiation.(2018.08-2020.11)
研究者
Zhen Zhang
Professor Zhang
Fudan University