Fuzheng Yiliu-1010
Primary Purpose
Colorectal Cancer Stage II and III
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Fuzheng Yiliu Formulation
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer Stage II and III
Eligibility Criteria
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).
Sites / Locations
- Guangdong Provincial Hospital of Chinese MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Fuzheng Yiliu group
control group
Arm Description
Outcomes
Primary Outcome Measures
Disease-free Survival
Secondary Outcome Measures
Full Information
NCT ID
NCT04459754
First Posted
July 2, 2020
Last Updated
July 2, 2020
Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04459754
Brief Title
Fuzheng Yiliu-1010
Official Title
Based on the Real World Prospective Cohort Study, Two-way Analysis of the Dominant Population and Corresponding Phenotypic Characteristics of Patients With Colorectal Cancer Treated by Fuzheng Yiliu Therapy Combined With Adjuvant Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Stage II and III
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
189 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fuzheng Yiliu group
Arm Type
Experimental
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Fuzheng Yiliu Formulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disease-free Survival
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
wei wang, MD
Phone
8613922255515
Email
ww1640@yeah.net
Facility Information:
Facility Name
Guangdong Provincial Hospital of Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Wang, MD
Phone
13922255515
Email
ww1640@yeah.net
12. IPD Sharing Statement
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Fuzheng Yiliu-1010
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