Status:
UNKNOWN
Fuzheng Yiliu-1010
Lead Sponsor:
Guangdong Provincial Hospital of Traditional Chinese Medicine
Conditions:
Colorectal Cancer Stage II and III
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT04459754
Start Date
June 29 2020
End Date
December 31 2024
Last Update
July 7 2020
Active Locations (1)
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1
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, China, 510000