Clinical trial NCT03349762: Huaier Granules for Prevention of Recurrence and Metastasis of Colorectal Cancer Patients Following Radical Surgery
Official title: A Real-World Study Investigating Huaier Granules for Prevention of Recurrence and Metastasis of Colorectal Cancer Patients Following Radical Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Keywords: Huaier Granule
multisite
open-label
prospective
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2017-11-22
Enrollment: 3060
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Colorectal cancer patients after radical surgery

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 efficacy and safety.

Eligibility 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.

Primary outcomes:
measure: Disease-Free Survival(DFS)
timeFrame: 36 months
measure: Overall survival(OS)
timeFrame: 36 months
measure: Local recurrence-Free Survival rate
timeFrame: 36 months
measure: Distant Metastasis-Free Survival rate
timeFrame: 36 months
Secondary outcomes:
measure: Change From Baseline in Quality of Life (QOL)
timeFrame: 36 months
measure: Incidence rate of Adverse events (AE)
timeFrame: 36 months
measure: Severity of Adverse events
timeFrame: 36 months
measure: Immunity function
timeFrame: 36 months
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
city: Harbin
country: China
facility: The First Clinical Hospital affiliated to Harbin Medical University
state: Heilongjiang
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Wuhan
country: China
facility: Hubei Cancer Hospita
state: Hubei
city: Wuhan
country: China
facility: Union Hospital Tongji College Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Hunan Provincial People's Hospital
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Changzhou
country: China
facility: Changzhou No.2 People's Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
city: Anshan
country: China
facility: Anshan Cancer Hospital
state: Liaoning
city: Anshan
country: China
facility: Ansteel Group General Hospital
state: Liaoning
city: Jinzhou
country: China
facility: The First Affiliated Hospital of Jinzhou Medical University
state: Liaoning
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
city: Zaozhuang
country: China
facility: Zaozhuang Municipal Hospital
state: Shandong
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Ürümqi
country: China
facility: First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Xishan Wang, Professor
role: PRINCIPAL_INVESTIGATOR
References: