PTC Drug Sensitivity Detection to Guide Postoperative Adjuvant of Colorectal Cancer

Not Applicable

Recruiting

• Conditions: Colo-rectal Cancer
• Interventions: Drug: adjuvant therapy based on 3D drug sensitivity test results of micro tumor (PTC) in vitro

• Registration Number: NCT05978349
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

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.

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

Study Timeline

• Study Start: 2022-02-14
• Status Verified: 2023-07
• Study First Submitted: 2023-07-27
• Study First Submitted QC: 2023-08-04
• Last Update Submitted: 2023-08-04
• Study First Posted: 2023-08-07
• Last Update Posted: 2023-08-07
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	adjuvant therapy based on 3D drug sensitivity test results of micro tumor (PTC) in vitro	Select adjuvant chemotherapy scheme according to 3D drug sensitivity test results of micro tumor (PTC) in vitro

Primary Outcome Measures

Name	Time	Method
Follow-up and record DFS of patients	3 years after enrollment	We follow-up the patients by outpatient/telephone/online message to find out their survival situation and record their Disease-free-survival time

Secondary Outcome Measures

Name	Time	Method
Consistency between drug sensitivity results and clinical outcomes	3 years after enrollment	Record the patient's PTC drug sensitivity results and the actual medication therapy, and record the patient's survival status through telephone follow-up, online follow-up and offline diagnosis to compare whether there is correlation between them.
Follow-up and record OS of patients	3 years after enrollment	We follow-up the patients by outpatient/telephone/online message to find out their tumor and survival situation and record their Overall Survival time
Follow-up and record ORR of patients	3 years after enrollment	We follow-up the patients by outpatient/telephone/online message to find out their tumor situation and record their Objective Response Rate
Follow-up and record PFS of patients	3 years after enrollment	We follow-up the patients by outpatient/telephone/online message to find out their tumor situation and record their Progress Free Survival time
Follow-up and record TTP of patients	3 years after enrollment	We follow-up the patients by outpatient/telephone/online message to find out their tumor situation and record their Time To Progress

Trial Locations

Locations (1)

Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences; 🇨🇳 Beijing, China/Beijing, China