Colorectal Cancer Stage II and IIIPhase 2NCT04459754
Fuzheng Yiliu-1010
A Phase 2 study testing Fuzheng Yiliu Formulation in people with Colorectal Cancer Stage II and III, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer Stage II and III
- What is being tested?
- Fuzheng Yiliu Formulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteChina
- Study dates
- 29 Jun 2020to 31 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, 510000
Wei Wang, MD, 13922255515, ww1640@yeah.net
About this study
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
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
- Being tested
- Fuzheng Yiliu Formulation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fuzheng Yiliu FormulationDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Fuzheng Yiliu group | Experimental | Not described Receives: Drug: Fuzheng Yiliu Formulation |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free Survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start29 Jun 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer Stage II and IIIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 189 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Wang, The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04459754
- Sponsor's protocol ID
- 2019KT1089
- Status last verified
- Jul 2020
- First submitted
- 2 Jul 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04459754
- Acronym / sponsor ID
- 2019KT1089
- Conditions
- Colorectal Cancer Stage II and III
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fuzheng Yiliu group | Experimental | Drug: Fuzheng Yiliu Formulation |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fuzheng Yiliu FormulationThe "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. | Drug | Fuzheng Yiliu group |
Primary outcome
Disease-free Survival
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fuzheng Yiliu Formulation in people with Colorectal Cancer Stage II and III, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact wei wang, MD (8613922255515, ww1640@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free Survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.