Using Huaier granules to prevent colorectal cancer recurrence after surgery
Official title: A Real-World Study Investigating Huaier Granules for Prevention of Recurrence and Metastasis of Colorectal Cancer Patients Following Radical Surgery
Run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · NCT03349762 · Data updated 2026-11-12
This study is testing if Huaier granules can help prevent colorectal cancer from coming back after surgery in patients with certain stages of the disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 3060 (estimated) |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Locations | 22 sites (Shijiazhuang, Hebei and 21 other locations) |
| Status | Recruiting |
| Started | November 2, 2018 |
| Main results expected | December 31, 2027 |
| Study ends | June 30, 2028 |
| Registry record updated | June 3, 2024 |
| Trial ID | NCT03349762 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are males and females aged 18-75 who have recently undergone radical surgery for stage IIB, IIC, or III colorectal cancer.
✕Probably not a fit
Patients with severe comorbidities, post-surgery complications, or those currently undergoing treatment for colorectal cancer will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study evaluates the efficacy and safety of Huaier granules in preventing the recurrence and metastasis of colorectal cancer in patients who have undergone radical surgery. It is a multisite, open-label, prospective study involving patients diagnosed with stage IIB, IIC, and III colorectal cancer. Participants will be monitored for their health outcomes following treatment with Huaier granules within two months post-surgery.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of cancer recurrence and metastasis in colorectal cancer patients after surgery.
How similar studies have gone: While the specific use of Huaier granules is novel, similar approaches in cancer recurrence prevention have shown promise in other studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Males or females ages 18-75 years; 2. The first time to the therapy of patients who received the radical surgery within two months, Postoperative histopathology confirms the diagnosis of colorectal cancer with stage IIB, IIC and III ( TNM classification) 3. ECOG score of 0-2; 4. No history of malignant tumors; 5. The patients are volunteered for the study, sign informed consent form and cooperate with Investigator to collect data. Exclusion Criteria: 1. Patients have basic diseases including heart diseases, cerebrovascular disease, lung disease, severe hypertension or diabetes with poor glycemic control; 2. confirmed infections after surgery ; 3. Patients who have post-surgery complications or who are currently under the influence of the radical surgery for colorectal cancer; 4. Being infected with syphilis or with other blood-borne infectious diseases; 5. Pregnancy or lactation; or women of childbearing potential not using contraception; 6. Patients who have taken Traditional Chinese Medicines with efficacy and indications similar to that of Huaier granule - including, but not limited to, compound Banmao capsule., Huachansu capsule, Kangai Injection and Pingxiao tablets; 7. Patients who are suffering from mental illness or Conditions that are considered not suitable for this study investigators.
Where it's running
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The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China Recruiting -
The First Clinical Hospital affiliated to Harbin Medical University
Harbin, Heilongjiang, China Recruiting -
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China Recruiting -
Hubei Cancer Hospita
Wuhan, Hubei, China Recruiting -
Union Hospital Tongji College Huazhong University of Science and Technology
Wuhan, Hubei, China Recruiting -
Hunan Provincial People's Hospital
Changsha, Hunan, China Recruiting
Show 16 more locations
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Xiangya Hospital Central South University
Changsha, Hunan, China Recruiting -
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, China Recruiting -
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China Recruiting -
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China Recruiting -
Anshan Cancer Hospital
Anshan, Liaoning, China Recruiting -
Ansteel Group General Hospital
Anshan, Liaoning, China Recruiting -
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, China Recruiting -
Shandong Provincial Hospital
Jinan, Shandong, China Recruiting -
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China Recruiting -
Yantai Yuhuangding Hospital
Yantai, Shandong, China Recruiting -
Zaozhuang Municipal Hospital
Zaozhuang, Shandong, China Recruiting -
First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China Recruiting -
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China Recruiting -
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China Recruiting -
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China Recruiting -
Fudan University Shanghai Cancer Center
Shanghai, China Recruiting
Study contacts
- Principal investigator: Xishan Wang, Professor — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study coordinator: Xishan Wang, Professor
- Email: wangxishanzy@sina.com
- Phone: +0086-13552367779
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.