RecruitingPhase 4NCT06090994

Prevention of Recurrence and Metastasis of Colorectal Cancer by Comparing Huaier With Capecitabine Monotherapy

A Prospective, Multicenter, Randomized, Parallel Controlled Study Comparing Huaier Granules With Capecitabine Monotherapy for the Prevention of Recurrence and Metastasis After Radical Resection of Stage II Colorectal Cancer

Sponsor

Fudan University

Enrollment

756 participants

Start Date

Oct 18, 2024

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer

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

Eligibility

Min Age: 18 Years

Inclusion Criteria8

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 Criteria8

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.

Interventions

DRUGHuaier 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.

DRUGCapecitabine

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.