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

Recruiting now · Phase 4

Conditions studied: Colorectal Cancer

In brief

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

Key facts

Study ID

NCT06090994

Run by

Fudan University

People needed

756

Starts

2024-10-18

Expected to finish

2029-11-01

Last updated by the study team

2025-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Sanjun Cai — Shanghai, Shanghai Municipality, China (enrolling)
• Jiangsu People's Hospital — Nanjing, Jiangsu, China (enrolling)
• Northern Jiangsu People's Hospital — Yangzhou, Jiangsu, China (enrolling)
• Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (enrolling)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China
• Ningbo Medical Center Lihuili Hospital — Ningbo, Zhejiang, China
• The First People's Hospital of Changzhou — Changzhou, Jiangsu, China
• Renji Hospital，Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China
• Zhejiang Cancer Hospita — Hangzhou, Zhejiang, China

Full record on ClinicalTrials.gov

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