Vitro 3D Drug Sensitivity Detection of Micro Tumor (PTC) Combined with Tumor Whole Exon (WES) Sequencing Technology to Guide Postoperative Adjuvant Treatment Strategy and Prognosis of Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The difference of 3-year disease-free survival rate of patients in both group
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. All exon (WES) data collection was used to predict postoperative survival in both groups.
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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
PTC test group
The adjuvant chemotherapy scheme was selected according to the 3D drug sensitivity test results of micro tumor (PTC) in vitro
干预措施: 5-fluorouracil + formyltetrahydrofolate/Oxaliplatin + 5-fluorouracil + formyltetrahydrofolate/Irinotecan + 5-fluorouracil + formyltetrahydrofolate/Cetuximab + 5-fluorouracil + formyltetrahydrofolate (Drug)
结局指标
主要结局
The difference of 3-year disease-free survival rate of patients in both group
时间窗: 3 years
Follow-up the survival status of patients, and calculate 3-year disease-free survival rate of patients in both group
次要结局
- The relation between MSI and clinical outcomes(3 years)
- The relation between dMMR and clinical outcomes(3 years)
- The relation between TMB and clinical outcomes(3 years)
- The difference of clinical outcomes of patients in both group(3 years)
- The difference of TTP of patients in both group(3 years)
- The difference of ORR of patients in both group(three years)
- The difference of DFS of patients in both group(3 years)
- The difference of PFS of patients in both group(3 years)
- The difference of OS of patients in both group(3 years)