Prevention of Recurrence and Metastasis of Colorectal Cancer by Comparing Huaier With Capecitabine Monotherapy
- Conditions
- Colorectal Cancer
- Interventions
- Drug: Huaier granuleDrug: Capecitabine
- Registration Number
- NCT06090994
- Lead Sponsor
- Fudan University
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 756
- Age ≥ 18 years old, regardless of gender.
- It is diagnosed as colorectal cancer by histopathology, TNM stage Ⅱ.
- Received radical resection of colorectal cancer (R0) within 12 weeks prior to enrollment.
- Not receiving neoadjuvant therapy before surgery, and not receiving any adjuvant therapy after surgery.
- ECOG score 0-2 points.
- According to the CSCO Colorectal Cancer Guidelines 2022, it meets the criteria for receiving monotherapy adjuvant therapy with capecitabine.
- Clear consciousness, language expression or reading ability, able to communicate normally, and cooperate in completing questionnaire assessments.
- Voluntarily join this study and sign an informed consent form.
- Low rectal cancer (occurring within 12 centimeters from the anal margin)
- Combining medical history of other malignant tumors.
- Known to be allergic to the components of Huaier granules or avoid or use Huaier granules with caution (only in the experimental group).
- Inability to take orally medication (experimental group, control group with oral medication included in standard treatment plan).
- Pregnant or lactating women or planned pregnancy preparation.
- In the past one month, the subjects have received Huaier granules or traditional Chinese patent medicines and simple preparations with similar efficacy or indications to Huaier granules (such as compound cantharides capsules, cinobufacin capsules, Kangai injection, Pingxiao tablets, please refer to the instruction manual for details).
- Refusal to cooperate with follow-up.
- Other reasons leading to the researcher's belief that it is not suitable to participate in this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Huaier Granule Huaier granule Oral administration of Huai'er granules, 10g once, 3 times a day, continued until the end of the study, intolerable toxicity, withdrawal from the study for any reason, disease progression or death, whichever occurs first; Or the researcher determines that the subject no longer benefits. It is recommended that Huai'er Granules be used for the first time within 14 days-2 months after surgery. Please refer to the drug instructions for specific usage. Capecitabine Capecitabine Oral administration, 1250mg/m\^2, twice a day (2500mg/m\^2/d),day 1-14,with one course of treatment every 3 weeks，please refer to the drug instructions for specific usage.
- Primary Outcome Measures
Name Time Method 3-year disease-free survival rate (DFS) start of treatment until 3-year follow-up The proportion of surviving patients who did not experience disease recurrence or metastasis within 3 years after R0 surgery.
- Secondary Outcome Measures
Name Time Method Quality of Life Score baseline period and start of treatment until 3-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.
1-year disease-free survival rate (DFS) start of treatment until 1-year follow-up The proportion of surviving patients who did not experience disease recurrence or metastasis within 1 years after R0 surgery.
2-year disease-free survival rate (DFS) start of treatment until 2-year follow-up The proportion of surviving patients who did not experience disease recurrence or metastasis within 2 years after R0 surgery.
Overall survival (OS) start of treatment until 3-year follow-up The time from randomization and enrollment on the day of the patient to death for any reason.
The incidence and severity of adverse events (AE) and severe adverse events (SAE) start of treatment until 3-year follow-up 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.
The incidence and severity of adverse reactions (ADR), severe adverse reactions (SADR), suspicious and unexpected severe adverse reactions (SUSAR) start of treatment until 3-year follow-up 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.
Trial Locations
- Locations (9)
Jiangsu People's Hospital
🇨🇳Nanjing, Jiangsu, China
Sanjun Cai
🇨🇳Shanghai, Shanghai, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
Northern Jiangsu People's Hospital
🇨🇳Yangzhou, Jiangsu, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Renji Hospital，Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
The First People's Hospital of Changzhou
🇨🇳Changzhou, Jiangsu, China
Ningbo Medical Center Lihuili Hospital
🇨🇳Ningbo, Zhejiang, China
Zhejiang Cancer Hospita
🇨🇳Hangzhou, Zhejiang, China