NCT06332716Unknown3 期
Research on the Correlation Between Organoid Drug Sensitivity Testing and Precise Treatment of Gastrointestinal Tumors
Jianjun Yang,MD1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2022年8月26日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Progression-free survival（PFS）
研究概览
简要总结
Study the correlation between in vitro drug sensitivity screening of digestive tract tumor organoids and their clinical efficacy in anti-tumor treatment, evaluate the use of digestive tract tumor organoid drug sensitivity to predict the therapeutic effect of anti-tumor drugs, and explore new methods for personalized and precise treatment of esophageal cancer, gastric cancer, colorectal cancer, and gastrointestinal stromal tumors.
详细描述
This trial is a single arm, multicenter, open label, prospective clinical study.
- Sample size This study is a clinical exploratory study and does not estimate sample size. It is expected to include 68 patients with digestive tract tumors, including 16 cases each of esophageal cancer, gastric cancer, and colorectal cancer, and 20 cases of gastrointestinal stromal tumors.
1.1Participation Center Approximately 10-15 research centers are involved nationwide. 2.Case selection 2.1Selection criteria
To be selected, all of the following conditions must be met:
- Age range from 18 to 75 years old, regardless of gender;
- Patients with esophageal cancer, gastric cancer, colorectal cancer, and gastrointestinal stromal tumors confirmed by histopathology/cytology;
- The subject's condition meets one of the following conditions:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with esophageal cancer, gastric cancer, colorectal cancer, and gastrointestinal stromal tumors confirmed by histopathology/cytology;
- •Esophageal cancer: clinical staging is stage II (cT1-2N1-3M0/cT3-4NOMO) or stage III (cT3-4aN1-3MO);
- •Gastric cancer: Clinical staging is stage II (cT1-2N1-3M0/cT3-4N0MO) or stage III (cT3-4aN1-3MO);
- •Colorectal cancer: clinical staging is stage II (cT1-2N1-3M0/cT3-4N0MO) or stage III (cT3-4aN1-3MO)
- •Gastrointestinal stromal tumors: Primary stromal tumors with locally advanced risk classification (tumor spontaneous rupture; tumor diameter>10cm; mitotic image>10/50HPF; tumor diameter>5cm and mitotic image count>5/50HPF; 5cm ≤ tumor diameter>2cm and mitotic image>5/50HPF non gastric primary stromal tumors; 10cm ≤ tumor diameter>5cm and mitotic image ≤ 5/50HPF non-gastric primary stromal tumors) or recurrent metastatic/unresectable gastrointestinal stromal tumors.
- •The patient or legal representative voluntarily participates in this study and signs an informed consent form.
排除标准
- •Suffering from systemic inflammatory diseases and/or coagulation disorders;
- •There are serious liver and kidney diseases, cardiovascular diseases, respiratory diseases or uncontrolled diabetes;
- •Suffering from other malignant tumors of the system;
- •Patients with mental illness who are unable to cooperate in completing the study;
- •Known allergies to potential chemotherapy drugs or surgical contraindications;
- •Patients whose condition cannot be reversed or in a dying state;
- •Unable to obtain sufficient tumor tissue through biopsy surgery for organoid culture and histological analysis;
- •Pregnancy or lactation, or planning to have a fertility plan within the next 6 months;
- •Poor health status, KPS score<70 points, or ECOG score ≥ 3 points;
- •Receiving any other anti-cancer drug treatment, biological therapy, radiation therapy, or immunosuppressive therapy within 4 weeks;
结局指标
主要结局
Progression-free survival（PFS）
时间窗: up to 100 months
Progression-free survival
次要结局
- Overall survival（OS）(up to 100 months)
研究者
Jianjun Yang,MD
Professor, Chief Physician
Xijing Hospital
研究点 (1)
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