Prevention of Recurrence and Metastasis of Colorectal Cancer by Comparing Huaier With Capecitabine Monotherapy
About this study
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
- Condition
- Colorectal Cancer
- Tested
- Huaier granule, Capecitabine
- Sponsor
- Fudan University
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 10
- Minimum age: 18 years
- Study condition: Colorectal Cancer
- 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 8
- 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.
Where
9 sites, 9 recruiting
Jiangsu People's Hospital
Nanjing, Jiangsu, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Sanjun Cai
Shanghai, Shanghai Municipality, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
Zhejiang Cancer Hospita
Hangzhou, Zhejiang, China
and 3 more sites on ClinicalTrials.gov
Contact
-
Sanjun Cai, PhD
+8618121299134
-
Fangqi Liu, PhD
+8613917902221
Potential match only. Final eligibility is determined by the study team.