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.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
134
Oral administration, 10g per dose (1 bag), 3 times a day, recommended for at least 6 months.
Rate of CEA conversion to negative
The proportion of patients whose CEA levels returned to normal at each visit to the total number of patients at that follow-up.
Time frame: start of treatment until 2-year follow-up
1 or 2-year disease-free survival rate (DFS)
The proportion of surviving patients who did not experience imaging recurrence, distant metastasis, or death within 1 or 2 years after enrollment.
Time frame: start of treatment until 2-year follow-up
Quality of Life Score
Evaluation using the EORTC QLQ-C30 (Chinese version) core quality of life scale developed by the European Organization for Cancer Research and Treatment.
Time frame: baseline period and start of treatment until 2-year follow-up
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