PTC Drug Sensitivity Detection to Guide Postoperative Adjuvant 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. 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) to Guide Postoperative Adjuvant Treatment Strategy and Prognosis Judgment of Colorectal Cancer--Prospective Clinical Study

Conditions
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Colo-rectal Cancer

Intervention / Treatment
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* Drug: adjuvant therapy based on 3D drug sensitivity test results of micro tumor (PTC) in vitro


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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>Select adjuvant chemotherapy scheme according to 3D drug sensitivity test results of micro tumor (PTC) in vitro | Drug: adjuvant therapy based on 3D drug sensitivity test results of micro tumor (PTC) in vitro<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>Formulate 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 |
| --- | --- | --- |
| Follow-up and record DFS of patients | We follow-up the patients by outpatient/telephone/online message to find out their survival situation and record their Disease-free-survival time | 3 years after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Follow-up and record TTP of patients | We follow-up the patients by outpatient/telephone/online message to find out their tumor situation and record their Time To Progress | 3 years after enrollment | 
| Consistency between drug sensitivity results and clinical outcomes | Record the patient's PTC drug sensitivity results and the actual medication therapy, and record the patient's survival status through telephone follow-up, online follow-up and offline diagnosis to compare whether there is correlation between them. | 3 years after enrollment | 
| Follow-up and record ORR of patients | We follow-up the patients by outpatient/telephone/online message to find out their tumor situation and record their Objective Response Rate | 3 years after enrollment | 
| Follow-up and record PFS of patients | We follow-up the patients by outpatient/telephone/online message to find out their tumor situation and record their Progress Free Survival time | 3 years after enrollment | 
| Follow-up and record OS of patients | We follow-up the patients by outpatient/telephone/online message to find out their tumor and survival situation and record their Overall Survival time | 3 years after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon cancer, rectal cancer, adjuvant therapy, PTC