Precision Chemotherapy Based on Organoid for Colorectal CancerPatient-Derived Tumor Organoid Drug Sensitivity for Colorectal Cancer: A Prospective, Multicentre，Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- 1. Progression-free survival
研究概览
简要总结
The purpose of this study is to investigate whether chemotherapy guided by patient-derived tumor organoid drug test can improve the outcomes of stage IV colorectal cancer.
详细描述
Fluorouracil-based chemotherapy is the standard treatment for stage IV colorectal cancer patients. However, the effects of chemotherapy remains limited. Patient-derived tumor organoids are increasingly used as tools for drug test and predicting drug response in the clinic, and have been showed to faithfully predict clinical outcomes of patients with CRC. A prospective clinical trial is needed to validate whether the in vitro sensitivity to chemotherapy regimens in organoids drug test is associated with a longer PFS in stage IV colorectal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age between 18 and 70
- •Histological confirmed colorectal cancer
- •American Society of Anesthesiologists (ASA) score I~III
- •No contraindication for chemotherapy
- •No evidence of other malignant tumor
排除标准
- •Refusing chemotherapy
- •Pregnant or breast-feeding women
- •Severe organ damage after chemotherapy, surgery or unable to continue to systemic chemotherapy
研究组 & 干预措施
Organoid guided chemotherapy
Patients will receive sensitive chemotherapy in organoid drug test once every two weeks for 6 cycles as adjuvant chemotherapy
干预措施: FOLFOX , FOLFIRI or FOLFOXIRI regimens (Drug)
FOLFOX regimen
Patients will receive FOLFOX regimen once every two weeks for 6 cycles as adjuvant chemotherapy
干预措施: FOLFOX or CapeOX regimens (Drug)
结局指标
主要结局
1. Progression-free survival
时间窗: up to 1 years
the time from randomization to relapse or death, whichever occurred first
次要结局
- Overall survival(up to 5 years)