Fuzheng Yiliu-1010

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    189
  • sponsor
    Guangdong Provincial Hospital of Traditional Chinese Medicine
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Updated on 19 February 2024
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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.

Details
Condition Colorectal Cancer Stage II and III
Age 18-75 years
Treatment Fuzheng Yiliu Formulation
Clinical Study IdentifierNCT04459754
SponsorGuangdong Provincial Hospital of Traditional Chinese Medicine
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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)
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