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
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences | Beijing | China/Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital |
China,
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 |
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