Vitro 3D Drug Sensitivity Detection of Micro Tumor (PTC) to Guide Postoperative Adjuvant Treatment Strategy and Prognosis Judgment of Colorectal Cancer--Prospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Follow-up and record DFS of patients
研究概览
简要总结
The research objectives is to compare vitro 3D drug sensitivity test results of micro tumor (PTC) with the clinical outcomes of patients, evaluate the consistency between the test results of the technology platform and the clinical prognosis, and explore the decision-making value and guiding significance of this technology in assisting the precise treatment of colorectal cancer. The completion of this study will provide real-world data support for the clinical application of micro tumor (PTC) in vitro 3D drug sensitivity detection technology, and provide more valuable reference basis for realizing the individualization and accuracy of colorectal cancer treatment and improving the clinical benefit rate.
详细描述
The study is a multi agency prospective cohort study in China. The subjects were patients aged 18 ~ 75 years with colorectal cancer diagnosed by histopathology or cytology. They must be colorectal cancer patients who have at least one assessable tumor focus, need adjuvant therapy after radical surgery, and have not received neoadjuvant therapy， ECoG physical condition score ≤ 2 points. And they must be voluntarily participate in and sign informed consent.
The patients were randomly divided into PTC drug sensitivity test group and control group. The PTC drug sensitivity test group selected the adjuvant chemotherapy scheme according to the 3D drug sensitivity test results of micro tumor (PTC) in vitro. The control group made adjuvant chemotherapy strategy according to clinical experience.
The primary endpoint was the non inferiority test, and the 3-year disease-free survival rate was T-C >- Δ
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
- 否
入选标准
- •Age 18 ~ 75 years old, regardless of gender
- •Patients with colorectal cancer diagnosed by histopathology or cytology
- •Colorectal cancer patients who need adjuvant therapy after radical surgery and have not received neoadjuvant therapy
- •Having at least one assessable tumor focus
- •ECoG physical condition score ≤ 2 points
- •Voluntarily participate and sign informed consent
排除标准
- •Patients diagnosed with metastasis
- •Patients who cannot obtain tumor samples
- •Pregnant and lactating women
- •Patients with poor compliance
- •Patients with severe cardiovascular and cerebrovascular complications who cannot receive adjuvant treatment
- •Patients with other malignant tumors
- •Suffering from serious mental and nervous system diseases
- •The researchers believe that patients should not be selected for this study
研究组 & 干预措施
experimental group
Select adjuvant chemotherapy scheme according to 3D drug sensitivity test results of micro tumor (PTC) in vitro
干预措施: adjuvant therapy based on 3D drug sensitivity test results of micro tumor (PTC) in vitro (Drug)
结局指标
主要结局
Follow-up and record DFS of patients
时间窗: 3 years after enrollment
We follow-up the patients by outpatient/telephone/online message to find out their survival situation and record their Disease-free-survival time
次要结局
- Consistency between drug sensitivity results and clinical outcomes(3 years after enrollment)
- Follow-up and record OS of patients(3 years after enrollment)
- Follow-up and record ORR of patients(3 years after enrollment)
- Follow-up and record PFS of patients(3 years after enrollment)
- Follow-up and record TTP of patients(3 years after enrollment)