Actively Recruiting
Prevention of Recurrence and Metastasis of Colorectal Cancer by Comparing Huaier With Capecitabine Monotherapy
Led by Fudan University · Updated on 2025-05-07
756
Participants Needed
9
Research Sites
262 weeks
Total Duration
On this page
Sponsors
F
Fudan University
Lead Sponsor
H
Huazhong University of Science and Technology
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a prospective, multicenter, randomized, parallel controlled study to evaluate the effectiveness of Huaier Granule in preventing recurrence and metastasis after radical resection of colorectal cancer
CONDITIONS
Official Title
Prevention of Recurrence and Metastasis of Colorectal Cancer by Comparing Huaier With Capecitabine Monotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Diagnosed with stage II colorectal cancer by histopathology
- Underwent radical (R0) resection of colorectal cancer within 12 weeks before enrollment
- No neoadjuvant therapy before surgery and no adjuvant therapy after surgery
- ECOG performance status score of 0 to 2
- Eligible for capecitabine monotherapy as adjuvant treatment per 2022 CSCO guidelines
- Able to communicate, understand, and complete questionnaires
- Willing to participate and sign informed consent
You will not qualify if you...
- Low rectal cancer located within 12 centimeters of the anal margin
- History of other malignant tumors
- Known allergy or caution required with Huaier granules (experimental group only)
- Unable to take oral medication
- Pregnant, breastfeeding, or planning pregnancy
- Used Huaier granules or similar traditional Chinese medicines in the past month
- Unwilling to comply with follow-up visits
- Any other condition deemed unsuitable for study participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
Not Yet Recruiting
2
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China, 213000
Not Yet Recruiting
3
Jiangsu People's Hospital
Nanjing, Jiangsu, China, 210029
Actively Recruiting
4
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China, 225001
Actively Recruiting
5
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
6
Sanjun Cai
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
7
Renji Hospital，Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200127
Not Yet Recruiting
8
Zhejiang Cancer Hospita
Hangzhou, Zhejiang, China, 310005
Not Yet Recruiting
9
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China, 315046
Not Yet Recruiting
Research Team
S
Sanjun Cai, PhD
CONTACT
F
Fangqi Liu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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