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Select adjuvant chemotherapy scheme according to 3D drug sensitivity test results of micro tumor (PTC) in vitro

Formulate adjuvant chemotherapy strategy based on clinical experience

Choose chemotherapeutic drugs（5-fluorouracil + formyltetrahydrofolate/Oxaliplatin + 5-fluorouracil + formyltetrahydrofolate/Irinotecan + 5-fluorouracil + formyltetrahydrofolate/Cetuximab + 5-fluorouracil + formyltetrahydrofolate） based on PTC drug sensitivity results.

adjuvant therapy based on 3D drug sensitivity test results of micro tumor (PTC) in vitro

Jiaolin Zhou, Professor

Jiaolin Zhou, MD

Guo Lin, Professor

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.

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

PTC Drug Sensitivity Detection to Guide Postoperative Adjuvant of Colorectal Cancer

Vitro 3D Drug Sensitivity Detection of Micro Tumor (PTC) to Guide Postoperative Adjuvant Treatment Strategy and Prognosis Judgment of Colorectal Cancer--Prospective Clinical Study

We follow-up the patients by outpatient/telephone/online message to find out their survival situation and record their Disease-free-survival time

We follow-up the patients by outpatient/telephone/online message to find out their tumor situation and record their Time To Progress

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.

We follow-up the patients by outpatient/telephone/online message to find out their tumor situation and record their Objective Response Rate

We follow-up the patients by outpatient/telephone/online message to find out their tumor situation and record their Progress Free Survival time

We follow-up the patients by outpatient/telephone/online message to find out their tumor and survival situation and record their Overall Survival time

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PTC Drug Sensitivity Detection to Guide Postoperative Adjuvant of Colorectal Cancer	NCT05978349	Colo-rectal Can...	adjuvant therap...	18 Years - 75 Years	Peking Union Medical College Hospital
PTC Drug Sensitivity Detection to Guide Postoperative Adjuvant of Colorectal Cancer	NCT05978349	Colo-rectal Can...	adjuvant therap...	18 Years - 75 Years	Peking Union Medical College Hospital

Spots Global Cancer Trial Database for adjuvant therapy based on 3d drug sensitivity test results of micro tumor (ptc) in vitro