Clinical trial NCT05978349: PTC Drug Sensitivity Detection to Guide Postoperative Adjuvant of Colorectal Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colo-rectal Cancer
Keywords: colon cancer
rectal cancer
adjuvant therapy
PTC
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Follow-up and record DFS of patients
timeFrame: 3 years after enrollment
Secondary outcomes:
measure: Follow-up and record TTP of patients
timeFrame: 3 years after enrollment
measure: Consistency between drug sensitivity results and clinical outcomes
timeFrame: 3 years after enrollment
measure: Follow-up and record ORR of patients
timeFrame: 3 years after enrollment
measure: Follow-up and record PFS of patients
timeFrame: 3 years after enrollment
measure: Follow-up and record OS of patients
timeFrame: 3 years after enrollment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
state: China/Beijing
Study officials:
affiliation: PUMCH
name: Guo Lin, Professor
role: STUDY_CHAIR
References: