About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients diagnosed with metastasis
Patients who cannot obtain tumor samples
Pregnant and lactating women
Patients with poor compliance
Trial design
Parallel
Treatments tested in this trial
5-fluorouracil + formyltetrahydrofolate/Oxaliplatin + 5-fluorouracil + formyltetrahydrofolate/Irinotecan + 5-fluorouracil + formyltetrahydrofolate/Cetuximab + 5-fluorouracil + formyltetrahydrofolate
DrugChoose chemotherapeutic drugs(5-fluorouracil + formyltetrahydrofolate/Oxaliplatin + 5-fluorouracil + formyltetrahydrofolate/Irinotecan + 5-fluorouracil + formyltetrahydrofolate/Cetuximab + 5-fluorouracil + formyltetrahydrofolate) based on PTC drug sensitivity results.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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.
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.
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.
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
Sponsors and contacts
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