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Trial Title:
PTC Drug Sensitivity Detection to Guide Postoperative Adjuvant of Colorectal Cancer
NCT ID:
NCT05978349
Condition:
Colo-rectal Cancer
Conditions: Official terms:
Rectal Neoplasms
Conditions: Keywords:
colon cancer
rectal cancer
adjuvant therapy
PTC
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
adjuvant therapy based on 3D drug sensitivity test results of micro tumor (PTC) in vitro
Description:
Choose chemotherapeutic drugs（5-fluorouracil + formyltetrahydrofolate/Oxaliplatin +
5-fluorouracil + formyltetrahydrofolate/Irinotecan + 5-fluorouracil +
formyltetrahydrofolate/Cetuximab + 5-fluorouracil + formyltetrahydrofolate） based on PTC
drug sensitivity results.
Arm group label:
experimental group
Other name:
PTC drug sensitivity results
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.
The primary endpoint was the non inferiority test, and the 3-year disease-free survival
rate was T-C >- Δ
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
Address:
City:
Beijing
Zip:
100000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiaolin Zhou, MD
Phone:
13910136704
Email:
conniezhjl@yahoo.com
Start date:
February 14, 2022
Completion date:
September 30, 2025
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05978349
