Prevention of Recurrence and Metastasis of Colorectal Cancer by Comparing Huaier With Capecitabine Monotherapy
NCT ID: NCT06090994
Last Updated: 2025-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
756 participants
INTERVENTIONAL
2024-10-18
2029-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Huaier granule
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.
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.
Capecitabine
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.
Interventions
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Huaier granule
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.
Capecitabine
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Huazhong University of Science and Technology
OTHER
Fudan University
OTHER
Responsible Party
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Sanjun Cai
professor
Principal Investigators
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Sanjun Cai, PhD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
Jiangsu People's Hospital
Nanjing, Jiangsu, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Sanjun Cai
Shanghai, Shanghai Municipality, China
Renji Hospital，Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Zhejiang Cancer Hospita
Hangzhou, Zhejiang, China
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China
Countries
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Central Contacts
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Sanjun Cai, PhD
Role: CONTACT
Fangqi Liu, PhD
Role: CONTACT
Facility Contacts
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Binbin Cui, PhD
Role: primary
Qicheng Lu, PhD
Role: primary
Yueming Sun, PhD
Role: primary
Daorong Wang, PhD
Role: primary
Ren H Zhao, PhD
Role: primary
Sanjun Cai
Role: primary
Zhe Cui, PhD
Role: primary
Haixing Jv, PhD
Role: primary
Qian Zhang, PhD
Role: backup
Wei Cui, PhD
Role: primary
Other Identifiers
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HE-202401
Identifier Type: -
Identifier Source: org_study_id
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