Fuzheng Yiliu-1010

Study Overview
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Brief Summary
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Real world study was used to evaluate the therapeutic effect of Fuzheng anti-tumor therapy on colorectal cancer patients in stage II and III after surgery and standard chemotherapy, and the prediction model of dominant population of Fuzheng anti-tumor therapy was constructed by using real-world data and gene expression profile data.

Official Title
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Based on the Real World Prospective Cohort Study, Two-way Analysis of the Dominant Population and Corresponding Phenotypic Characteristics of Patients With Colorectal Cancer Treated by Fuzheng Yiliu Therapy Combined With Adjuvant Chemotherapy

Conditions
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Colorectal Cancer Stage II and III

Intervention / Treatment
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* Drug: Fuzheng Yiliu Formulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The age of the patients was 18-75 years old; Radical resection of colorectal cancer (negative margin) was performed; Patients with stage II high risk and stage III colorectal cancer confirmed by histology; No liver, peritoneal or distant metastasis was found; Patients with colorectal cancer who received standard chemotherapy or radiotherapy after operation and had no recurrence or metastasis at the end of radiotherapy and chemotherapy; ECoG (Eastern Cooperative Oncology Group) score was 0-1; KPS score was 70 or above; Liver function: SGOT and SGPT were less than 1.5 times of normal value, bilirubin was less than 1.5 mg / dl; Renal function: creatinine < 1.8mg/dl. Exclusion Criteria: Allergic to the drug of this scheme; Pregnant or lactating women with fertility requirements during the study period; Severe hypertension, coronary heart disease, diabetes and so on, which are under control for half a year due to cardiovascular accident and poor drug control, are accompanied with other uncontrollable benign diseases such as lung, kidney, liver, infection, etc; Participate in other studies before and during treatment; There was a history of other malignant tumors or multi-source tumors within one year; Chronic hepatitis B or C (high copy viral DNA) or activity in HIV infection history or active phase; Patients with tuberculosis or seizures who need to be treated (e.g. steroids or antiepileptic therapy).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fuzheng Yiliu group<br> | Drug: Fuzheng Yiliu Formulation<br>* The prescription for colorectal cancer Fuzheng Yiliu formulation is a combination of 13 herbal components and it is available in granules form to be dissolved in hot water for consumption.<br>|
| No Intervention: control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free Survival |  | 3 years |