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

November 1, 2024 updated by: Peking Union Medical College Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PTC test group
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
Choose chemotherapeutic drugs（5-fluorouracil + formyltetrahydrofolate/Oxaliplatin + 5-fluorouracil + formyltetrahydrofolate/Irinotecan + 5-fluorouracil + formyltetrahydrofolate/Cetuximab + 5-fluorouracil + formyltetrahydrofolate） based on PTC drug sensitivity results.
Other Names:
  • PTC drug sensitivity results
No Intervention: control group
Making adjuvant chemotherapy strategy based on clinical experience

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The difference of 3-year disease-free survival rate of patients in both group
Time Frame: 3 years
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
Time Frame: 3 years
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
Time Frame: 3 years
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
Time Frame: 3 years
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
Time Frame: 3 years
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
Time Frame: 3 years
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
Time Frame: three years
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
Time Frame: 3 years
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
Time Frame: 3 years
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
Time Frame: 3 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Study Chair: Guole Lin, Peking Union Medical College Hospital
  • Study Director: Jiaolin Zhou, Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

May 3, 2022

First Submitted That Met QC Criteria

June 15, 2022

First Posted (Actual)

June 21, 2022

Study Record Updates

Last Update Posted (Estimated)

November 4, 2024

Last Update Submitted That Met QC Criteria

November 1, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PekingUMCHPTC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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