Patient-derived Organoids, Patient-derived Organoids-tumor-infiltrating Lymphocyte Coculture System, and Patient-derived Organotypic Tissue Spheroids for Drug Screen
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
- Objective response rate (ORR)
研究概览
简要总结
This clinical trial aims to use the patient-derived organoid (PDO), Patient-derived organoids-tumor-infiltrating lymphocyte coculture system (PDO-TIL) and patient-derived organotypic tissue spheroids (PDOTS) to simulate the tumor microenvironment in cancer patients. The culture system can be used for pre-clinical validation of drugs and screening of drugs to treat sensitive people and provide individualized treatment for patients with liver cancer. This model is used to explore the molecular mechanism of drug resistance and to find intervention strategies to further improve the response rate of drugs. This study is expected to provide an ideal platform for drug screening and drug resistance research in liver cancer patients, which can replace experimental animal models, and guide personalized medication for liver cancer patients, so as to improve the overall prognosis of patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old, male or female.
- •Liver cancer or metastatic liver cancer diagnosed clinically or pathologically, at least one measurable lesion.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-
- •Patient has given written informed consent.
- •The function of important organs meets the requirements.
- •Non-surgical sterilization or women of childbearing age need to use a medically-accepted contraceptive (such as an intrauterine device, contraceptive or condom) during the study period and within 3 months after the end of the study treatment period.
排除标准
- •The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroid Hyperfunction; patients with vitiligo; complete remission of asthma in childhood, can be included without any intervention after adulthood; asthma patients who require bronchodilators for medical intervention cannot be included).
- •The patient is using immunosuppressive agents or systemic hormonal therapy to achieve immunosuppressive purposes (agents amount > 10 mg/day of prednisone or other therapeutic hormones), and continue to use within 2 weeks before enrollment.
- •Have clinical symptoms or diseases that are not well controlled.
- •Significant clinically significant bleeding symptoms or a clear bleeding tendency within 3 months prior to randomization.
- •Arterial/venous thrombosis in the first 6 months of randomization.
- •According to the investigator, the patient has other factors that may affect the results of the study or lead to the termination of the study, such as alcohol abuse, drug abuse, other serious diseases (including mental illness) requiring combined treatment, and serious laboratory abnormalities.
结局指标
主要结局
Objective response rate (ORR)
时间窗: 1 years
Evaluated by researchers based on the RECIST 1.1 standard
次要结局
- To the relief time (TOR)(1 years)
- 12-month survival rate(12 months)
- Progression free survival (PFS)(Evaluated by researchers based on the RECIST 1.1 standard)
- Overall survival (OS)(1 years)
- Relapse-free survival (RFS)(1 year)
- Duration of relief (DOR)(1 years)
- Disease control rate (DCR)(1 years)
- 6-month survival rate(6 months)
研究者
Hu Bo
Doctor
Shanghai Zhongshan Hospital