Clinical trial
Vitro 3D Drug Sensitivity Detection of Micro Tumor (PTC) to Guide Postoperative Adjuvant Treatment Strategy and Prognosis Judgment of Colorectal Cancer--Prospective Clinical Study
Name
2022-PUMCH-B-005
Description
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.
Trial arms
Trial start
2022-02-14
Estimated PCD
2025-09-30
Trial end
2025-09-30
Status
Recruiting
Treatment
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.
Arms:
experimental group
Other names:
PTC drug sensitivity results
Size
150
Primary endpoint
Follow-up and record DFS of patients
3 years after enrollment
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}
Updated at
2023-08-07
1 organization
1 product
1 indication
Organization
Peking Union Medical College HospitalIndication
Colorectal Cancer