Observation of Clinical Consistency of Organoid-on-chips Drug Sensitivity Detection in Chemotherapy for Prostate Cancer Patients With Visceral Metastasis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- ORR(Objective Response Rate)
研究概览
简要总结
This project plans to establish an organoid chip model of prostate cancer patients with internal organ metastasis from surgical or biopsy tissue sources, and test the sensitivity of commonly used chemotherapy drugs based on organoid chip drug sensitivity testing technology to screen out sensitive individualized treatment plans.
详细描述
This project plans to establish an organoid chip model of prostate cancer patients with internal organ metastasis from surgical or biopsy tissue sources, and test the sensitivity of commonly used chemotherapy drugs based on organoid chip drug sensitivity testing technology to screen out sensitive individualized treatment plans;The final medication regimen for patients is determined by doctors based on their experience and in vitro drug sensitivity results. The actual clinical efficacy of medication is tracked for patients, and the organoid chip drug sensitivity detection model is analyzed as a predictor of the sensitivity, specificity, and accuracy of anti-tumor chemotherapy drugs, providing data reference for clinical applications.At the same time, analyze the accuracy of drug sensitivity testing results and clinical empirical medication.If patients are treated with a chemotherapy combined with immunotherapy regimen, the in vitro sensitivity of immune drugs will be determined using organoid-immune co-culture technology, and exploratory research on the predictive performance of immune models will be conducted in conjunction with clinical medication.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with visceral metastasis of prostate cancer diagnosed clinically or pathologically;
- •Age ≥ 18 years old;
- •ECOG score ≤ 2 points or ECOG score 3-4 points due to tumor progression;
- •Normal liver and kidney function, serum transaminase ALT<66 U/L, AST<36 U/L, total bilirubin<22 umol/L, creatinine<106 umol/L, urea nitrogen<6.1 mmol/L; Normal bone marrow function: neutrophil count ≥ 1800/mm3 and platelet count ≥ 100000/mm3;
- •Can obtain surgical or biopsy samples;
- •Patients voluntarily join this study and sign an informed consent form.
排除标准
- •Patients with severe heart, liver, kidney, and peripheral nervous system diseases, as well as autoimmune diseases such as hyperthyroidism and hypothyroidism; Systemic lupus erythematosus, etc;
- •Patients who are unable to obtain tissue samples;
- •Subjects with active pulmonary tuberculosis (TB);
- •Subjects who are preparing for or have previously undergone tissue/organ transplantation;
- •Exclusion criteria are not listed, but the researchers believe that patients who are not suitable to participate in this clinical study.
结局指标
主要结局
ORR(Objective Response Rate)
时间窗: 18 months
Selecting ORR as the primary endpoint from clinical efficacy evaluation indicators.Evaluation of the best objective response rate (ORR) for each treatment according to RECIST 1.1. The best ORR is the best response reached during treatment according to RECIST 1.1 criteria.
Clinical Consistency
时间窗: 18 months
Sensitivity, specificity, and accuracy of drug sensitivity testing results based on successfully constructed organoids for predicting the main clinical efficacy evaluation indicators.
次要结局
- Changes in tumor markers levels(18 months)
- PFS(Progression-free survival)(18 months)