Huaier Granules for Prevention of Recurrence and Metastasis of Colorectal Cancer Patients Following Radical Surgery

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03349762
• Other study ID #: HE-201709
• Status: Recruiting
• Start date: November 2, 2018
• Est. completion date: June 30, 2028

Study information

• Verified date: May 2024
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Xishan Wang, Professor
• Phone: +0086-13552367779
• Email: wangxishanzy[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To evaluate the efficacy and safety of Huaier granules for Prevention of Recurrence and Metastasis of colorectal cancer patients following radical surgery

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 efficacy and safety.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3060
• Est. completion date: June 30, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Recurrence

Locations

Country	Name	City	State
China	Anshan Cancer Hospital	Anshan	Liaoning
China	Ansteel Group General Hospital	Anshan	Liaoning
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing
China	Hunan Provincial People's Hospital	Changsha	Hunan
China	Xiangya Hospital Central South University	Changsha	Hunan
China	Changzhou No.2 People's Hospital	Changzhou	Jiangsu
China	The First Clinical Hospital affiliated to Harbin Medical University	Harbin	Heilongjiang
China	The Second Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Shandong Provincial Hospital	Jinan	Shandong
China	The First Affiliated Hospital of Jinzhou Medical University	Jinzhou	Liaoning
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Fudan University Shanghai Cancer Center	Shanghai
China	The Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin
China	First Affiliated Hospital of Xinjiang Medical University	Ürümqi	Xinjiang
China	Hubei Cancer Hospita	Wuhan	Hubei
China	Union Hospital Tongji College Huazhong University of Science and Technology	Wuhan	Hubei
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	Northern Jiangsu People's Hospital	Yangzhou	Jiangsu
China	Yantai Yuhuangding Hospital	Yantai	Shandong
China	Zaozhuang Municipal Hospital	Zaozhuang	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Xi Shan Wang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-Free Survival(DFS)	Disease free survival (DFS) was defined as the time from participation to the time of tumor recurrence or death.	36 months
Primary	Overall survival(OS)	OS was defined as the time from participation to death from any cause or last patient last visit.	36 months
Primary	Local recurrence-Free Survival rate	The proportion of Local recurrence-Free Survival subjects to the total number of subjects.	36 months
Primary	Distant Metastasis-Free Survival rate	The proportion of Distant Metastasis-Free Surviva subjects to the total number of subjects.	36 months
Secondary	Change From Baseline in Quality of Life (QOL)	Quality of Life (QOL) were measured using supplemental quality of life questions. Item score range(12 items): 1 (worst symptom) to 5 (no symptom). Change: score at 36 months minus score at baseline.	36 months
Secondary	Incidence rate of Adverse events (AE)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.	36 months
Secondary	Severity of Adverse events	An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	36 months
Secondary	Immunity function	Immunity function was measured with Immune cells counts and positive rate.	36 months