An Pancancer Study on Organoid-on-chips Technological System Based on Biopsy Samples and Its Efficacy in Predicting the Response to MFOLFOX6 Infusion in Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Success rate of organoid culture of biopsy samples
研究概览
简要总结
This study is aimed to establish an organoid-on-chips technological system based on biopsy samples and evaluate its efficacy in predicting the response to mFOLFOX6 infusion in patients with hepatocellular carcinoma (HCC).
详细描述
This is a two-stage, multi-center real-world observational study. In stage 1, we aim to establish the technical system of organoid-on-chips culture system based on biopsy samples from patients with malignant solid tumors including breast cancer, lung cancer, liver cancer, bile duct cancer and pancreatic cancer, et.al. In stage 2, we aim to evaluate the predicting efficacy of the established organoid-on-chips system in HCC patients who undergo hepatic artery infusion (HAI) with mFOLFOX6 (oxaliplatin 85mg/m^2, d1, HAI for 2h; calcium folinate 200mg/m^2, d1, HAI for 1h; fluorouracil 400mg/m^2, hepatic artery injection; fluorouracil 2400mg/m^2, HAI for 46h).
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Success rate of organoid culture of biopsy samples
时间窗: 2 years
The number of successful cases of Organoid culture divided by the number of enrolled cases
Accuracy of Organoid drug sensitivity test in predicting the response to mFOLFOX6 infusion in HCC patients with successful Organoid culture
时间窗: 3 years
The sensitivity and specificity of drug sensitivity test in patients with successful Organoid culture to predict the response mRECIST) to mFOLFOX6 infusion in HCC
次要结局
- Accuracy of Organoid drug sensitivity test in predicting the response to mFOLFOX6 infusion in intent-to-treat HCC population(3 years)
- The predictive effect of Organoid drug sensitivity test on the survival of patients with HCC.(4 years)