Prevention of Recurrence and Metastasis of Colorectal Cancer by Comparing Huaier With Capecitabin… (NCT06090994) | Clinical Trial Compass
RecruitingPhase 4
Prevention of Recurrence and Metastasis of Colorectal Cancer by Comparing Huaier With Capecitabine Monotherapy
China756 participantsStarted 2024-10-18
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
3-year disease-free survival rate (DFS)
Timeframe: start of treatment until 3-year follow-up