Clinical trial Recruiting at 22 sites Observational Ages 18 to 75

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.

More Colorectal Cancer trials

Quick facts

Study typeObservational
Ages18 Years to 75 Years
SexAll
Enrollment3060 (estimated)
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
Academic / other
Locations22 sites (Shijiazhuang, Hebei and 21 other locations)
StatusRecruiting
StartedNovember 2, 2018
Main results expectedDecember 31, 2027
Study endsJune 30, 2028
Registry record updatedJune 3, 2024
Trial IDNCT03349762 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.