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Using Huaier granules to prevent colorectal cancer recurrence after surgery

A Real-World Study Investigating Huaier Granules for Prevention of Recurrence and Metastasis of Colorectal Cancer Patients Following Radical Surgery

Observational Cancer Institute and Hospital, Chinese Academy of Medical Sciences · NCT03349762

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 typeObservational
Enrollment3060 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other
Locations22 sites (Shijiazhuang, Hebei and 21 other locations)
Trial IDNCT03349762 on ClinicalTrials.gov

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.

Who should consider this trial

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.

Not a fit: Patients with severe comorbidities, post-surgery complications, or those currently undergoing treatment for colorectal cancer will not benefit from this study.

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 performed: While the specific use of Huaier granules is novel, similar approaches in cancer recurrence prevention have shown promise in other studies.

Eligibility criteria

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 this trial is running

Shijiazhuang, Hebei and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Colorectal CancerHuaier Granulemultisiteopen-labelprospective
Last reviewed 2026-06-13 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.