Colorectal Cancer Stage II and III
Conditions
Brief summary
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.
Interventions
DRUGFuzheng Yiliu Formulation
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.
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. The age of the patients was 18-75 years old; 2. Radical resection of colorectal cancer (negative margin) was performed; 3. Patients with stage II high risk and stage III colorectal cancer confirmed by histology; 4. No liver, peritoneal or distant metastasis was found; 5. 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; 6. ECoG (Eastern Cooperative Oncology Group) score was 0-1; KPS score was 70 or above; 7. Liver function: SGOT and SGPT were less than 1.5 times of normal value, bilirubin was less than 1.5 mg / dl; 8. Renal function: creatinine \< 1.8mg/dl.
Exclusion criteria
1. Allergic to the drug of this scheme; 2. Pregnant or lactating women with fertility requirements during the study period; 3. 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; 4. Participate in other studies before and during treatment; 5. There was a history of other malignant tumors or multi-source tumors within one year; 6. Chronic hepatitis B or C (high copy viral DNA) or activity in HIV infection history or active phase; 7. Patients with tuberculosis or seizures who need to be treated (e.g. steroids or antiepileptic therapy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free Survival | 3 years |
Countries
China
Contacts
Primary Contactwei wang, MD
Outcome results
None listed