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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status

Enrolling

Conditions

Chemotherapy Effect

PTC

Colon Cancer

Exon Mutation

Rectal Cancer

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05424692

PekingUMCHPTC

Details and patient eligibility

About

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.

Full 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

Enrollment

200 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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