Fuzheng Yiliu-1010

Guangdong Provincial Hospital of Traditional Chinese Medicine

Status and phase: Enrolling; Phase 2

Conditions: Colorectal Cancer Stage II and III

Treatments: Drug: Fuzheng Yiliu Formulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04459754

2019KT1089

Details and patient eligibility

About

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.

Enrollment: 189 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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189 participants in 2 patient groups

Fuzheng Yiliu group

Experimental group

Treatment:

Drug: Fuzheng Yiliu Formulation

control group

No Intervention group