Clinical trial NCT05424692: Drug Sensitivity Detection of Micro Tumor (PTC) to Guide Postoperative Adjuvant Treatment Strategy of Colorectal Cancer
Official title: Vitro 3D Drug Sensitivity Detection of Micro Tumor (PTC) Combined with Tumor Whole Exon (WES) Sequencing Technology to Guide Postoperative Adjuvant Treatment Strategy and Prognosis of Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colon Cancer
Rectal Cancer
Chemotherapy Effect
PTC
Exon Mutation
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: 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. All exon (WES) data collection was used to predict postoperative survival in both groups.

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: The difference of 3-year disease-free survival rate of patients in both group
timeFrame: 3 years
Secondary outcomes:
measure: The relation between TMB and clinical outcomes
timeFrame: 3 years
measure: The relation between MSI and clinical outcomes
timeFrame: 3 years
measure: The relation between dMMR and clinical outcomes
timeFrame: 3 years
measure: The difference of clinical outcomes of patients in both group
timeFrame: 3 years
measure: The difference of TTP of patients in both group
timeFrame: 3 years
measure: The difference of ORR of patients in both group
timeFrame: three years
measure: The difference of DFS of patients in both group
timeFrame: 3 years
measure: The difference of PFS of patients in both group
timeFrame: 3 years
measure: The difference of OS of patients in both group
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Guole Lin
role: STUDY_CHAIR
affiliation: Peking Union Medical College Hospital
name: Jiaolin Zhou
role: STUDY_DIRECTOR
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