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

Last updated: May 6, 2025
Sponsor: Fudan University
Overall Status: Active - Recruiting

Phase

4

Condition

Colorectal Cancer

Cancer

Colon Cancer

Treatment

Huaier granule

Capecitabine

Clinical Study ID

NCT06090994
HE-202401
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 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 toenrollment.

  • Not receiving neoadjuvant therapy before surgery, and not receiving any adjuvanttherapy after surgery.

  • ECOG score 0-2 points.

  • According to the CSCO Colorectal Cancer Guidelines 2022, it meets the criteria forreceiving monotherapy adjuvant therapy with capecitabine.

  • Clear consciousness, language expression or reading ability, able to communicatenormally, and cooperate in completing questionnaire assessments.

  • Voluntarily join this study and sign an informed consent form.

Exclusion

Exclusion Criteria:

  • 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 Huaiergranules with caution (only in the experimental group).

  • Inability to take orally medication (experimental group, control group with oralmedication 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 traditionalChinese patent medicines and simple preparations with similar efficacy orindications to Huaier granules (such as compound cantharides capsules, cinobufacincapsules, Kangai injection, Pingxiao tablets, please refer to the instruction manualfor details).

  • Refusal to cooperate with follow-up.

  • Other reasons leading to the researcher's belief that it is not suitable toparticipate in this study.

Study Design

Total Participants: 756
Treatment Group(s): 2
Primary Treatment: Huaier granule
Phase: 4
Study Start date:
October 18, 2024
Estimated Completion Date:
November 30, 2029

Study 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.

Connect with a study center

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang 150081
    China

    Site Not Available

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu 213000
    China

    Site Not Available

  • Jiangsu People's Hospital

    Nanjing, Jiangsu 210029
    China

    Active - Recruiting

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu 225001
    China

    Active - Recruiting

  • Renji Hospital,Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai 200127
    China

    Site Not Available

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai 200025
    China

    Active - Recruiting

  • Sanjun Cai

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

  • Zhejiang Cancer Hospita

    Hangzhou, Zhejiang 310005
    China

    Site Not Available

  • Ningbo Medical Center Lihuili Hospital

    Ningbo, Zhejiang 315046
    China

    Site Not Available

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