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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking Union Medical College Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 5-fluorouracil + formyltetrahydrofolate/Oxaliplatin + 5-fluorouracil + formyltetrahydrofolate/Irinotecan + 5-fluorouracil + formyltetrahydrofolate/Cetuximab + 5-fluorouracil + formyltetrahydrofolate

    Drug

    Choose 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

200 Participants
are divided into 2 treatment groups
Group A: PTC test groupExperimental treatment 1 intervention
Group B: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
3 years

Secondary outcomes

1

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.

Time frame
3 years
2

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.

Time frame
3 years
3

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.

Time frame
3 years
4

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

Time frame
3 years

Other outcomes

Sponsors and contacts

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