Status:
RECRUITING
Huaier Granules for Prevention of Recurrence and Metastasis of Colorectal Cancer Patients Following Radical Surgery
Lead Sponsor:
Xi Shan Wang
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-75 years
Brief Summary
To evaluate the efficacy and safety of Huaier granules for Prevention of Recurrence and Metastasis of colorectal cancer patients following radical surgery
Detailed Description
This is a multisite, open-label, prospective study investigating Huaier Granule for Prevention of Recurrence and Metastasis of colorectal cancer patients following radical surgery，to evaluate the effi...
Eligibility Criteria
Inclusion
- Males or females ages 18-75 years;
- 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)
- ECOG score of 0-2;
- No history of malignant tumors;
- The patients are volunteered for the study, sign informed consent form and cooperate with Investigator to collect data.
Exclusion
- Patients have basic diseases including heart diseases, cerebrovascular disease, lung disease, severe hypertension or diabetes with poor glycemic control;
- confirmed infections after surgery ;
- Patients who have post-surgery complications or who are currently under the influence of the radical surgery for colorectal cancer;
- Being infected with syphilis or with other blood-borne infectious diseases;
- Pregnancy or lactation; or women of childbearing potential not using contraception;
- 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;
- Patients who are suffering from mental illness or Conditions that are considered not suitable for this study investigators.
Key Trial Info
Start Date :
November 2 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
3060 Patients enrolled
Trial Details
Trial ID
NCT03349762
Start Date
November 2 2018
End Date
June 30 2028
Last Update
June 3 2024
Active Locations (22)
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1
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
2
The First Clinical Hospital affiliated to Harbin Medical University
Harbin, Heilongjiang, China
3
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
4
Hubei Cancer Hospita
Wuhan, Hubei, China