This is a prospective, multicenter, randomized, parallel controlled study to evaluate the effectiveness of Huaier Granule in preventing recurrence and metastasis after radical resection of colorectal cancer
It is expected to include 756 patients with colorectal cancer (CRC) who were diagnosed as stage II and underwent radical resection (R0) according to the CSCO colorectal cancer guidelines 2022 and met the criteria for cabetabine monotherapy in the study center from July 2024 to June 2026. The experimental group was treated with Huaier Granule monotherapy, and 378 patients were expected to be included; The control group was treated with capecitabine monotherapy, and 378 cases were expected to be included. Patients in the experimental group began using Huaier granules within 14 days-2 months after surgery. Patients in control group received capecitabine treatment, with one course of treatment every 3 weeks, for a total of 4-6 courses. Patients will be visited every 12 weeks (± 14 days) for the first two years after enrollment, and every 24 weeks (± 14 days) for the third year, until the end of the study, withdrawal from the study for any reason, or death, whichever occurs first.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
756
Oral administration, 10g once, 3 times a day, starting within 14 days-2 months after surgery. Please refer to the medication manual for specific usage.
Oral administration, 1250mg/m\^2, twice a day (2500mg/m\^2/d),day 1-14,with one course of treatment every 3 weeks, for a total of 4-6 courses.
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGThe First People's Hospital of Changzhou
Changzhou, Jiangsu, China
NOT_YET_RECRUITINGJiangsu People's Hospital
3-year disease-free survival rate (DFS)
The proportion of surviving patients who did not experience disease recurrence or metastasis within 3 years after R0 surgery.
Time frame: start of treatment until 3-year follow-up
1-year disease-free survival rate (DFS)
The proportion of surviving patients who did not experience disease recurrence or metastasis within 1 years after R0 surgery.
Time frame: start of treatment until 1-year follow-up
2-year disease-free survival rate (DFS)
The proportion of surviving patients who did not experience disease recurrence or metastasis within 2 years after R0 surgery.
Time frame: start of treatment until 2-year follow-up
Overall survival (OS)
The time from randomization and enrollment on the day of the patient to death for any reason.
Time frame: start of treatment until 3-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 3-year follow-up
The incidence and severity of adverse events (AE) and severe adverse events (SAE)
The definition and severity grading of AE and SAE refer to the corresponding descriptions in the definition and evaluation section of adverse events, and the incidence rate is defined as the proportion of patients with AE and SAE to the corresponding total population.
Time frame: start of treatment until 3-year follow-up
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Nanjing, Jiangsu, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
RECRUITINGRuijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGSanjun Cai
Shanghai, Shanghai Municipality, China
RECRUITINGRenji Hospital,Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGZhejiang Cancer Hospita
Hangzhou, Zhejiang, China
NOT_YET_RECRUITINGNingbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China
NOT_YET_RECRUITINGThe incidence and severity of adverse reactions (ADR), severe adverse reactions (SADR), suspicious and unexpected severe adverse reactions (SUSAR)
The definition and severity grading of ADR, severe ADR, and SUSAR refer to the corresponding descriptions in the definition and evaluation section of adverse events. The incidence rate is defined as the proportion of patients with ADR, severe ADR, and SUSAR to the corresponding total population.
Time frame: start of treatment until 3-year follow-up