PTC Drug Sensitivity Detection to Guide Postoperative Adjuvant of Colorectal Cancer

NCT ID: NCT05978349

Last Updated: 2023-08-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-14
• Study Completion Date: 2025-09-30

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

Conditions

Colo-rectal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

experimental group

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Choose chemotherapeutic drugs（5-fluorouracil + formyltetrahydrofolate/Oxaliplatin + 5-fluorouracil + formyltetrahydrofolate/Irinotecan + 5-fluorouracil + formyltetrahydrofolate/Cetuximab + 5-fluorouracil + formyltetrahydrofolate） based on PTC drug sensitivity results.

control group

Formulate adjuvant chemotherapy strategy based on clinical experience

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

PTC drug sensitivity results

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guo Lin, Professor

Role: STUDY_CHAIR

PUMCH

Locations

Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

Beijing, China/Beijing, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiaolin Zhou, Professor

Role: CONTACT

conniezhjl@yahoo.com

13910136704

Facility Contacts

Jiaolin Zhou, MD

Role: primary

conniezhjl@yahoo.com

13910136704

Other Identifiers

2022-PUMCH-B-005

Identifier Type: -

Identifier Source: org_study_id