Comparing Huaier Granule and Capecitabine for Preventing Colorectal Cancer Recurrence
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
This study is testing whether Huaier Granule can help prevent colorectal cancer from coming back after surgery, compared to the standard treatment with capecitabine, for people who have had stage II colorectal cancer.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 756 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Locations | 9 sites (Harbin, Heilongjiang and 8 other locations) |
| Trial ID | NCT06090994 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of Huaier Granule compared to capecitabine monotherapy in preventing recurrence and metastasis of colorectal cancer after radical resection. The study will enroll 756 patients diagnosed with stage II colorectal cancer who have undergone surgery. Participants will be randomly assigned to receive either Huaier Granule or capecitabine, with follow-up visits scheduled every 12 weeks for the first two years and every 24 weeks in the third year. The trial aims to assess the long-term outcomes of both treatment approaches.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with stage II colorectal cancer who have undergone radical resection within the last 12 weeks.
Not a fit: Patients with low rectal cancer or those with a history of other malignant tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option that may reduce the risk of colorectal cancer recurrence and metastasis.
How similar studies have performed: Other studies have shown promising results with similar approaches, but this specific comparison of Huaier Granule and capecitabine is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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: * 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 this trial is running
Harbin, Heilongjiang and 8 other locations
- Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (Not_yet_recruiting)
- The First People's Hospital of Changzhou — Changzhou, Jiangsu, China (Not_yet_recruiting)
- Jiangsu People's Hospital — Nanjing, Jiangsu, China (Recruiting)
- Northern Jiangsu People's Hospital — Yangzhou, Jiangsu, China (Recruiting)
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
- Sanjun Cai — Shanghai, Shanghai Municipality, China (Recruiting)
- Renji Hospital，Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
- Zhejiang Cancer Hospita — Hangzhou, Zhejiang, China (Not_yet_recruiting)
- Ningbo Medical Center Lihuili Hospital — Ningbo, Zhejiang, China (Not_yet_recruiting)
Study contacts
- Principal investigator: Sanjun Cai, PhD — Fudan University
- Study coordinator: Sanjun Cai, PhD
- Phone: +8618121299134
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.