PTC Drug Sensitivity Detection to Guide Postoperative Adjuvant of Colorectal Cancer

Colo-rectal Cancer Clinical Trial

Official title:

Vitro 3D Drug Sensitivity Detection of Micro Tumor (PTC) to Guide Postoperative Adjuvant Treatment Strategy and Prognosis Judgment of Colorectal Cancer--Prospective Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05978349
• Other study ID #: 2022-PUMCH-B-005
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: July 2023
• Source: Peking Union Medical College Hospital
• Contact: Jiaolin Zhou, Professor
• Phone: 13910136704
• Email: conniezhjl[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colo-rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• adjuvant therapy based on 3D drug sensitivity test results of micro tumor (PTC) in vitro
Choose chemotherapeutic drugs(5-fluorouracil + formyltetrahydrofolate/Oxaliplatin + 5-fluorouracil + formyltetrahydrofolate/Irinotecan + 5-fluorouracil + formyltetrahydrofolate/Cetuximab + 5-fluorouracil + formyltetrahydrofolate) based on PTC drug sensitivity results.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences	Beijing	China/Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Follow-up and record DFS of patients	We follow-up the patients by outpatient/telephone/online message to find out their survival situation and record their Disease-free-survival time	3 years after enrollment
Secondary	Follow-up and record TTP of patients	We follow-up the patients by outpatient/telephone/online message to find out their tumor situation and record their Time To Progress	3 years after enrollment
Secondary	Consistency between drug sensitivity results and clinical outcomes	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.	3 years after enrollment
Secondary	Follow-up and record ORR of patients	We follow-up the patients by outpatient/telephone/online message to find out their tumor situation and record their Objective Response Rate	3 years after enrollment
Secondary	Follow-up and record PFS of patients	We follow-up the patients by outpatient/telephone/online message to find out their tumor situation and record their Progress Free Survival time	3 years after enrollment
Secondary	Follow-up and record OS of patients	We follow-up the patients by outpatient/telephone/online message to find out their tumor and survival situation and record their Overall Survival time	3 years after enrollment