Fuzheng Yiliu-1010

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine

Criteria

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).