To evaluate the efficacy and safety of Huaier granules for Prevention of Recurrence and Metastasis of colorectal cancer patients following radical surgery
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Disease-Free Survival(DFS) — 36 months Disease free survival (DFS) was defined as the time from participation to the time of tumor recurrence or death.
Overall survival(OS) — 36 months OS was defined as the time from participation to death from any cause or last patient last visit.
Local recurrence-Free Survival rate — 36 months The proportion of Local recurrence-Free Survival subjects to the total number of subjects.
Distant Metastasis-Free Survival rate — 36 months The proportion of Distant Metastasis-Free Surviva subjects to the total number of subjects.
Trial sites (22)
Facility
City
Region
Status
The Fourth Hospital of Hebei Medical University
Shijiazhuang
Hebei
Recruiting
The First Clinical Hospital affiliated to Harbin Medical University
Harbin
Heilongjiang
Recruiting
The Second Affiliated Hospital of Harbin Medical University
Harbin
Heilongjiang
Recruiting
Hubei Cancer Hospita
Wuhan
Hubei
Recruiting
Union Hospital Tongji College Huazhong University of Science and Technology
Wuhan
Hubei
Recruiting
Hunan Provincial People's Hospital
Changsha
Hunan
Recruiting
Xiangya Hospital Central South University
Changsha
Hunan
Recruiting
Changzhou No.2 People's Hospital
Changzhou
Jiangsu
Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou
Jiangsu
Recruiting
Northern Jiangsu People's Hospital
Yangzhou
Jiangsu
Recruiting
Anshan Cancer Hospital
Anshan
Liaoning
Recruiting
Ansteel Group General Hospital
Anshan
Liaoning
Recruiting
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou
Liaoning
Recruiting
Shandong Provincial Hospital
Jinan
Shandong
Recruiting
The Affiliated Hospital of Qingdao University
Qingdao
Shandong
Recruiting
Yantai Yuhuangding Hospital
Yantai
Shandong
Recruiting
Zaozhuang Municipal Hospital
Zaozhuang
Shandong
Recruiting
First Affiliated Hospital of Xi'an Jiaotong University
Xi’an
Shanxi
Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Tianjin Municipality
Recruiting
First Affiliated Hospital of Xinjiang Medical University
Ürümqi
Xinjiang
Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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