To Explore the Effect of Huaier Granule on the Negative Conversion Rate After the CEA Level Increases Again After Colorectal Cancer Surgery
October 30, 2024 updated by: Ye Xu, Fudan University
Objective to Explore the Effect of Huaier Granule on the Negative Conversion Rate of Patients Whose Carcinoembryonic Antigen (CEA) Level Increases Again After Radical Resection of Colorectal Cancer
This study is a prospective, observational and exploratory study to explore the effect of Huaier Granule on the negative conversion rate of patients with increased CEA levels after colorectal cancer surgery.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
This study is a prospective, single center, observational study, expected to include patients who visited the selected research center from December 2022 to December 2024 and were pathologically diagnosed with stage I-III colorectal cancer and underwent R0 radical resection surgery.
During routine clinical follow-up within one year after radical surgery, if serum CEA>5.2ng/ml
occurs, patients may choose whether to use Huaier granules to prevent recurrence and metastasis according to their wishes.
Patients who agree to use Huaier granules will enter the observation group; Patients who do not agree to use it will enter the control group.
After the subjects are enrolled, they will be visited every 1 month ± 7 days in the first year, and every 3 months ± 14 days starting from the second year according to clinical routine diagnosis and treatment, until imaging examination determines disease progression, the end of the study, intolerable toxicity, withdrawal from the study for any reason or death, or the researcher determines no longer benefiting, whichever occurs first.
Study Type
Interventional
Enrollment (Estimated)
134
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ye Xu, PhD
- Phone Number: +8613817171710
- Email: xu_shirley021@163.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age ≥18 years old, gender not limited
- Diagnosed with colorectal cancer through histopathology, pTNM stage I-III
- Previously underwent radical resection for colorectal cancer, with a postoperative evaluation of R0
- Imaging did not detect recurrence or distant metastasis
- Serum CEA>5.2ng/ml within 1 year after surgery (found during routine clinical follow-up)
- Clear consciousness, language expression or reading ability, able to communicate normally, and cooperate to complete the questionnaire evaluation
- Voluntary participation in this study, good compliance, and signing of informed consent form.
Exclusion Criteria:
- Known to be allergic to the components of Huaier Granule, or to avoid or use Huaier Granule with caution (observation group)
- Cannot take medicine orally
- Have received anti-tumor traditional Chinese patent medicines and simple preparations treatment within 1 month before enrollment (subject to the instructions)
- Combining medical history of other malignant tumors
- Diabetes with serious heart, cerebrovascular and lung diseases, severe hypertension and poor blood sugar control
- Suffering from intestinal diverticulitis, rectal polyps, colitis, pancreatitis, cirrhosis, hepatitis, etc
- Currently participating in clinical trials of other drugs
- Pregnant or lactating women or those planning to conceive
- Refusing to cooperate with follow-up visits
- Other reasons led the investigators to believe that it was not suitable to participate in this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Huaier Granule
Oral administration of Huaier granule, 10g (1 bag) each time, 3 times a day, is recommended for at least 6 months until there is imaging progression of the disease, the end of the study, intolerable toxicity, withdrawal or death from the study for any reason, or the researcher determines that there is no longer benefit, whichever occurs first.
|
Oral administration, 10g per dose (1 bag), 3 times a day, recommended for at least 6 months.
Other Names:
|
|
No Intervention: Routine clinical treatment
During routine clinical follow-up, patients who underwent R0 resection were found to have abnormally elevated levels of CEA, and therefore no intervention was generally given.
If there is imaging progress, intolerable toxicity, or withdrawal from the study for any reason during the research period (whichever occurs first), routine clinical treatment will be administered.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of CEA conversion to negative
Time Frame: start of treatment until 2-year follow-up
|
The proportion of patients whose CEA levels returned to normal at each visit to the total number of patients at that follow-up.
|
start of treatment until 2-year follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
1 or 2-year disease-free survival rate (DFS)
Time Frame: start of treatment until 2-year follow-up
|
The proportion of surviving patients who did not experience imaging recurrence, distant metastasis, or death within 1 or 2 years after enrollment.
|
start of treatment until 2-year follow-up
|
|
Quality of Life Score
Time Frame: baseline period and start of treatment until 2-year follow-up
|
Evaluation using the EORTC QLQ-C30 (Chinese version) core quality of life scale developed by the European Organization for Cancer Research and Treatment.
|
baseline period and start of treatment until 2-year follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The changes (rate values) of tumor markers (including but not limited to CA199, CA24-2, CA72-4, and CA50) compared to baseline
Time Frame: start of treatment until 2-year follow-up
|
The differences in tumor marker levels between treatment and baseline.
|
start of treatment until 2-year follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ye Xu, PhD, Fudan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 1, 2024
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
December 1, 2028
Study Registration Dates
First Submitted
October 29, 2024
First Submitted That Met QC Criteria
October 29, 2024
First Posted (Actual)
October 30, 2024
Study Record Updates
Last Update Posted (Actual)
October 31, 2024
Last Update Submitted That Met QC Criteria
October 30, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HE-202203
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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