Fuzheng Yiliu-1010

NCT ID: NCT04459754

Last Updated: 2020-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-29
• Study Completion Date: 2024-12-31

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.

Conditions

Colorectal Cancer Stage II and III

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fuzheng Yiliu group

Group Type: EXPERIMENTAL

Fuzheng Yiliu Formulation

Intervention Type: DRUG

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.

control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fuzheng 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.

Intervention Type: DRUG

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Wei Wang

Guangzhou University of Chinese Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

wei wang, MD

Role: CONTACT

ww1640@yeah.net

8613922255515

Facility Contacts

Wei Wang, MD

Role: primary

ww1640@yeah.net

13922255515

Other Identifiers

2019KT1089

Identifier Type: -

Identifier Source: org_study_id