Status:
RECRUITING
Prevention of Recurrence and Metastasis of Colorectal Cancer by Comparing Huaier With Capecitabine Monotherapy
Lead Sponsor:
Fudan University
Collaborating Sponsors:
Huazhong University of Science and Technology
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2029
Estimated Enrollment :
756 Patients enrolled
Trial Details
Trial ID
NCT06090994
Start Date
October 18 2024
End Date
November 1 2029
Last Update
May 7 2025
Active Locations (9)
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1
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
2
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China, 213000
3
Jiangsu People's Hospital
Nanjing, Jiangsu, China, 210029
4
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China, 225001