Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | Select adjuvant chemotherapy scheme according to 3D drug sensitivity test results of micro tumor (PTC) in vitro |
|
| control group | No Intervention | Formulate adjuvant chemotherapy strategy based on clinical experience |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adjuvant therapy based on 3D drug sensitivity test results of micro tumor (PTC) in vitro | Drug | Choose chemotherapeutic drugs（5-fluorouracil + formyltetrahydrofolate/Oxaliplatin + 5-fluorouracil + formyltetrahydrofolate/Irinotecan + 5-fluorouracil + formyltetrahydrofolate/Cetuximab + 5-fluorouracil + formyltetrahydrofolate） based on PTC drug sensitivity results. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Consistency between drug sensitivity results and clinical outcomes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiaolin Zhou, Professor | Contact | 13910136704 | conniezhjl@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Guo Lin, Professor | PUMCH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences | Recruiting | Beijing | China/Beijing | 100000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D066298 | In Vitro Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
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 |
| 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 |
| 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 |
| 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 |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |