Drug Sensitivity Detection of Micro Tumor (PTC) to Guide Postoperative Adjuvant Treatment Strategy of Colorectal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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Chemotherapy Effect, PTC, Exon Mutation, Colon Cancer, Rectal Cancer

Intervention / Treatment
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* Drug: 5-fluorouracil + formyltetrahydrofolate/Oxaliplatin + 5-fluorouracil + formyltetrahydrofolate/Irinotecan + 5-fluorouracil + formyltetrahydrofolate/Cetuximab + 5-fluorouracil + formyltetrahydrofolate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PTC test group<br>The adjuvant chemotherapy scheme was selected according to the 3D drug sensitivity test results of micro tumor (PTC) in vitro | Drug: 5-fluorouracil + formyltetrahydrofolate/Oxaliplatin + 5-fluorouracil + formyltetrahydrofolate/Irinotecan + 5-fluorouracil + formyltetrahydrofolate/Cetuximab + 5-fluorouracil + formyltetrahydrofolate<br>* Choose chemotherapeutic drugs（5-fluorouracil + formyltetrahydrofolate/Oxaliplatin + 5-fluorouracil + formyltetrahydrofolate/Irinotecan + 5-fluorouracil + formyltetrahydrofolate/Cetuximab + 5-fluorouracil + formyltetrahydrofolate） based on PTC drug sensitivity results.<br>* Other names: PTC drug sensitivity results;|
| No Intervention: control group<br>Making adjuvant chemotherapy strategy based on clinical experience | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference of 3-year disease-free survival rate of patients in both group | Follow-up the survival status of patients, and calculate 3-year disease-free survival rate of patients in both group | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relation between TMB and clinical outcomes | Use tumor whole exon (WES) sequencing to detect the Tumor Mutation Burden (TMB) of patients, and use correlation analysis to detect whether it's risk factor of clinical outcomes. | 3 years | 
| The relation between MSI and clinical outcomes | Use tumor whole exon (WES) sequencing to detect the Microsatellite Instability (MSI) of patients, and use correlation analysis to detect whether it's risk factor of clinical outcomes. | 3 years | 
| The relation between dMMR and clinical outcomes | Use tumor whole exon (WES) sequencing to detect the Deficient Mismatch Repair (dMMR) of patients, and use correlation analysis to detect whether it's risk factor of clinical outcomes. | 3 years | 
| The difference of clinical outcomes of patients in both group | Follow-up the health status and weather tumor recurrence and metastasis of patients, and evaluate whether the test results of extended drug regimen correspond with clinical outcomes | 3 years | 
| The difference of TTP of patients in both group | Follow-up the results of patients' periodic reviews and calculate Time To Progress (TTP） of patients in both group, and use survival analysis to detect whether the two group has difference in TTP. | 3 years | 
| The difference of ORR of patients in both group | Follow-up the results of patients' periodic reviews and calculate Objective Response Rate (ORR） of patients in both group, and use survival analysis to detect whether the two group has difference in ORR. | three years | 
| The difference of DFS of patients in both group | Follow-up the results of patients' periodic reviews and calculate Disease Free Survival (DFS) of patients in both group, and use survival analysis to detect whether the two group has difference in DFS. | 3 years | 
| The difference of PFS of patients in both group | Follow-up the results of patients' periodic reviews and calculate Progress Free Survival (PFS） of patients in both group, and use survival analysis to detect whether the two group has difference in PFS. | 3 years | 
| The difference of OS of patients in both group | Follow-up the results of patients' periodic reviews and calculate Overall Survival (OS） of patients in both group, and use survival analysis to detect whether the two group has difference in OS. | 3 years |