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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
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.
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
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Start Date
September 1, 2021
Primary Completion Date
September 1, 2025
Completion Date
September 1, 2027
Last Updated
November 4, 2024
200
ESTIMATED participants
5-fluorouracil + formyltetrahydrofolate/Oxaliplatin + 5-fluorouracil + formyltetrahydrofolate/Irinotecan + 5-fluorouracil + formyltetrahydrofolate/Cetuximab + 5-fluorouracil + formyltetrahydrofolate
DRUG
Lead Sponsor
Peking Union Medical College Hospital
NCT04704661
NCT06696768
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