RecruitingPhase 4NCT06090994

Prevention of Recurrence and Metastasis of Colorectal Cancer by Comparing Huaier With Capecitabine Monotherapy

A Prospective, Multicenter, Randomized, Parallel Controlled Study Comparing Huaier Granules With Capecitabine Monotherapy for the Prevention of Recurrence and Metastasis After Radical Resection of Stage II Colorectal Cancer


Sponsor

Fudan University

Enrollment

756 participants

Start Date

Oct 18, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two oral treatments for stage II colorectal cancer after surgery: a standard chemotherapy drug called capecitabine versus a traditional Chinese herbal medicine called Huaier (Trametes robiniophila Murr.). Researchers want to see if Huaier is as effective as or better than chemotherapy at preventing cancer from returning. **You may be eligible if...** - You are 18 or older - You have been diagnosed with stage II colorectal cancer confirmed by pathology - You had a complete surgical removal of your tumor (R0 resection) within the last 12 weeks - You have not had any chemotherapy or radiation before or after surgery - Your physical condition is acceptable (ECOG 0–2) - Your doctor has determined you should receive oral chemotherapy after surgery **You may NOT be eligible if...** - Your tumor is in the low rectum (within 12 cm of the anus) - You have a history of another cancer - You are allergic to Huaier granules or capecitabine - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHuaier granule

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.

DRUGCapecitabine

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.


Locations(9)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

The First People's Hospital of Changzhou

Changzhou, Jiangsu, China

Jiangsu People's Hospital

Nanjing, Jiangsu, China

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Sanjun Cai

Shanghai, Shanghai Municipality, China

Renji Hospital,Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Zhejiang Cancer Hospita

Hangzhou, Zhejiang, China

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT06090994


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