Trial Title:
Prevention of Recurrence and Metastasis of Colorectal Cancer by Comparing Huaier With Capecitabine Monotherapy
NCT ID:
NCT06090994
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Neoplasm Metastasis
Recurrence
Capecitabine
Conditions: Keywords:
Huaier granule
colorectal cancer
capecitabine
recurrence and metastasis
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Huaier granule
Description:
Oral administration, 10g once, 3 times a day, starting within 14 days-2 months after
surgery. Please refer to the medication manual for specific usage.
Arm group label:
Huaier Granule
Other name:
Z20000109（NMPA Approval Number）
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
Oral administration, 1250mg/m^2, twice a day (2500mg/m^2/d),day 1-14,with one course of
treatment every 3 weeks, for a total of 4-6 courses.
Arm group label:
Capecitabine
Summary:
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
Detailed description:
It is expected to include 756 patients with colorectal cancer (CRC) who were diagnosed as
stage II and underwent radical resection (R0) according to the CSCO colorectal cancer
guidelines 2022 and met the criteria for cabetabine monotherapy in the study center from
July 2024 to June 2026. The experimental group was treated with Huaier Granule
monotherapy, and 378 patients were expected to be included; The control group was treated
with capecitabine monotherapy, and 378 cases were expected to be included. Patients in
the experimental group began using Huaier granules within 14 days-2 months after surgery.
Patients in control group received capecitabine treatment, with one course of treatment
every 3 weeks, for a total of 4-6 courses. Patients will be visited every 12 weeks (± 14
days) for the first two years after enrollment, and every 24 weeks (± 14 days) for the
third year, until the end of the study, withdrawal from the study for any reason, or
death, whichever occurs first.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age ≥ 18 years old, regardless of gender.
- It is diagnosed as colorectal cancer by histopathology, TNM stage Ⅱ.
- Received radical resection of colorectal cancer (R0) within 12 weeks prior to
enrollment.
- Not receiving neoadjuvant therapy before surgery, and not receiving any adjuvant
therapy after surgery.
- ECOG score 0-2 points.
- According to the CSCO Colorectal Cancer Guidelines 2022, it meets the criteria for
receiving monotherapy adjuvant therapy with capecitabine.
- Clear consciousness, language expression or reading ability, able to communicate
normally, and cooperate in completing questionnaire assessments.
- Voluntarily join this study and sign an informed consent form.
Exclusion Criteria:
- Low rectal cancer (occurring within 12 centimeters from the anal margin)
- Combining medical history of other malignant tumors.
- Known to be allergic to the components of Huaier granules or avoid or use Huaier
granules with caution (only in the experimental group).
- Inability to take orally medication (experimental group, control group with oral
medication included in standard treatment plan).
- Pregnant or lactating women or planned pregnancy preparation.
- In the past one month, the subjects have received Huaier granules or traditional
Chinese patent medicines and simple preparations with similar efficacy or
indications to Huaier granules (such as compound cantharides capsules, cinobufacin
capsules, Kangai injection, Pingxiao tablets, please refer to the instruction manual
for details).
- Refusal to cooperate with follow-up.
- Other reasons leading to the researcher's belief that it is not suitable to
participate in this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Zip:
150081
Country:
China
Contact:
Last name:
Binbin Cui, PhD
Phone:
+8613351112888
Facility:
Name:
The First People's Hospital of Changzhou
Address:
City:
Changzhou
Zip:
213000
Country:
China
Contact:
Last name:
Qicheng Lu, PhD
Phone:
+8613915087018
Facility:
Name:
Jiangsu People's Hospital
Address:
City:
Nanjing
Zip:
210029
Country:
China
Contact:
Last name:
Yueming Sun, PhD
Phone:
+8613505188397
Facility:
Name:
Northern Jiangsu People's Hospital
Address:
City:
Yangzhou
Zip:
225001
Country:
China
Contact:
Last name:
Daorong Wang, PhD
Phone:
+8618051062590
Facility:
Name:
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Address:
City:
Shanghai
Zip:
200025
Country:
China
Contact:
Last name:
Ren H Zhao, PhD
Phone:
+8613918805942
Facility:
Name:
Sanjun Cai
Address:
City:
Shanghai
Zip:
200032
Country:
China
Contact:
Last name:
Sanjun Cai
Phone:
+8618121299134
Facility:
Name:
Renji Hospital，Shanghai Jiao Tong University School of Medicine
Address:
City:
Shanghai
Zip:
200127
Country:
China
Contact:
Last name:
Zhe Cui, PhD
Phone:
+8613512177595
Facility:
Name:
Zhejiang Cancer Hospita
Address:
City:
Hangzhou
Zip:
310005
Country:
China
Contact:
Last name:
Haixing Jv, PhD
Phone:
+8613858184823
Contact backup:
Last name:
Qian Zhang, PhD
Phone:
+8613588296045
Facility:
Name:
Ningbo Medical Center Lihuili Hospital
Address:
City:
Ningbo
Zip:
315046
Country:
China
Contact:
Last name:
Wei Cui, PhD
Phone:
+8613506842539
Start date:
August 2024
Completion date:
November 2029
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Collaborator:
Agency:
Huazhong University of Science and Technology
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06090994
