PTC Drug Sensitivity Detection to Guide Postoperative Adjuvant of Colorectal Cancer

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Colo-rectal Cancer

Treatments: Drug: adjuvant therapy based on 3D drug sensitivity test results of micro tumor (PTC) in vitro

Study type: Interventional

Funder types: Other

Identifiers

NCT05978349

2022-PUMCH-B-005

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.

The primary endpoint was the non inferiority test, and the 3-year disease-free survival rate was T-C >- Δ

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 ~ 75 years old, regardless of gender
2. Patients with colorectal cancer diagnosed by histopathology or cytology
3. Colorectal cancer patients who need adjuvant therapy after radical surgery and have not received neoadjuvant therapy
4. Having at least one assessable tumor focus
5. ECoG physical condition score ≤ 2 points
6. Voluntarily participate and sign informed consent

Exclusion criteria

1. Patients diagnosed with metastasis
2. Patients who cannot obtain tumor samples
3. Pregnant and lactating women
4. Patients with poor compliance
5. Patients with severe cardiovascular and cerebrovascular complications who cannot receive adjuvant treatment
6. Patients with other malignant tumors
7. Suffering from serious mental and nervous system diseases
8. The researchers believe that patients should not be selected for this study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

experimental group

Experimental group

Description:

Select adjuvant chemotherapy scheme according to 3D drug sensitivity test results of micro tumor (PTC) in vitro

Treatment:

Drug: adjuvant therapy based on 3D drug sensitivity test results of micro tumor (PTC) in vitro

control group

No Intervention group

Description:

Formulate adjuvant chemotherapy strategy based on clinical experience