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

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

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

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer

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 efficacy and safety.

• Study Type: Observational
• Enrollment (Estimated): 3060

Contacts and Locations

• Study Contact: Name: Xishan Wang, Professor; Phone Number: +0086-13552367779; Email: wangxishanzy@sina.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Cancer Hospital Chinese Academy of Medical Sciences
    • Contact: Xishan Wang
  • Shanghai, China
    • Recruiting
    • Fudan University Shanghai Cancer Center
    • Contact: Xinxiang Li
  • Hebei
    • Shijiazhuang, Hebei, China
      • Recruiting
      • The Fourth Hospital of Hebei Medical University
      • Contact: Guiying Wang
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • Recruiting
      • The Second Affiliated Hospital of Harbin Medical University
      • Contact: Guiyu Wang
    • Harbin, Heilongjiang, China
      • Recruiting
      • The First Clinical Hospital affiliated to Harbin Medical University
      • Contact: Daxun Piao
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Hubei Cancer Hospita
      • Contact: Shaozhong Wei
    • Wuhan, Hubei, China
      • Recruiting
      • Union Hospital Tongji College Huazhong University of Science And Technology
      • Contact: Kaixiong Tao
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Hunan Provincial People's Hospital
      • Contact: Zhongcheng Huang
    • Changsha, Hunan, China
      • Recruiting
      • Xiangya Hospital Central South University
      • Contact: Zihua Chen
  • Jiangsu
    • Changzhou, Jiangsu, China
      • Recruiting
      • Changzhou No.2 People's Hospital
      • Contact: Liming Tang
    • Xuzhou, Jiangsu, China
      • Recruiting
      • The Affiliated Hospital of Xuzhou Medical University
      • Contact: Jun Song
    • Yangzhou, Jiangsu, China
      • Recruiting
      • Northern Jiangsu People's Hospital
      • Contact: Rongdao Wang
  • Liaoning
    • Anshan, Liaoning, China
      • Recruiting
      • Anshan Cancer Hospital
      • Contact: Yuyang Dong
    • Anshan, Liaoning, China
      • Recruiting
      • Ansteel Group General Hospital
      • Contact: Dengbin Wu
    • Jinzhou, Liaoning, China
      • Recruiting
      • The First Affiliated Hospital of Jinzhou Medical University
      • Contact: Hang Lu
  • Shandong
    • Jinan, Shandong, China
      • Recruiting
      • Shandong Provincial Hospital
      • Contact: Leping Li
    • Qingdao, Shandong, China
      • Recruiting
      • The Affiliated Hospital of Qingdao University
      • Contact: Yun Lu
    • Yantai, Shandong, China
      • Recruiting
      • Yantai Yuhuangding Hospital
      • Contact: Zhongchuan Lv
    • Zaozhuang, Shandong, China
      • Recruiting
      • Zaozhuang Municipal Hospital
      • Contact: Junling Hou
  • Shanxi
    • Xi'an, Shanxi, China
      • Recruiting
      • First Affiliated Hospital of Xi'an JiaoTong University
      • Contact: Chengxue Dang
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • Tianjin Medical University Cancer Institute and Hospital
      • Contact: dalu kong, professor; Phone Number: 1862221078; Email: kongdl@hotmail.com
  • Xinjiang
    • Ürümqi, Xinjiang, China
      • Recruiting
      • First Affiliated Hospital of Xinjiang Medical University
      • Contact: Wenbin Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Colorectal cancer patients after radical surgery

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Observational 1; Radiotherapy or Chemotherapy
Observational 2; Huaier Granule & Radiotherapy or chemotherapy
Observational 3; Huaier Granules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Overall survival(OS)	OS was defined as the time from participation to death from any cause or last patient last visit.	36 months
Local recurrence-Free Survival rate	The proportion of Local recurrence-Free Survival subjects to the total number of subjects.	36 months
Distant Metastasis-Free Survival rate	The proportion of Distant Metastasis-Free Surviva subjects to the total number of subjects.	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Immunity function	Immunity function was measured with Immune cells counts and positive rate.	36 months

Collaborators and Investigators

• Sponsor: Xi Shan Wang
• Investigators: Principal Investigator: Xishan Wang, Professor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2018
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: November 14, 2017
• First Submitted That Met QC Criteria: November 19, 2017
• First Posted (Actual): November 22, 2017

Study Record Updates

• Last Update Posted (Actual): December 28, 2023
• Last Update Submitted That Met QC Criteria: December 27, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: open-label; prospective; Huaier Granule; multisite
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Recurrence
• Other Study ID Numbers: HE-201709

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No