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

Last updated: November 1, 2024
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colon Cancer

Rectal Cancer

Rectal Disorders

Treatment

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

Clinical Study ID

NCT05424692
PekingUMCHPTC
  • Ages 18-75
  • All Genders

Study Summary

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

Inclusion

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 havenot received neoadjuvant therapy

  • Having at least one assessable tumor focus

  • ECoG physical condition score ≤ 2 points

  • Voluntarily participate and sign informed consent

Exclusion

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 cannotreceive 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 Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: 5-fluorouracil + formyltetrahydrofolate/Oxaliplatin + 5-fluorouracil + formyltetrahydrofolate/Irinotecan + 5-fluorouracil + formyltetrahydrofolate/Cetuximab + 5-fluorouracil + formyltetrahydrofolate
Phase:
Study Start date:
September 01, 2021
Estimated Completion Date:
September 01, 2027

Study 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

Connect with a study center

  • Peking Union Medical College Hospital

    Beijing, Beijing 100730
    China

    Active - Recruiting

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