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Effect and Safety of Huaier Granule Versus SOX Regimen in Gastric Cancer Patients
Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Summary
This is a prospective, multi-center, open-label, randomised controlled study. The purpose of this study is to evaluate the efficacy and safety of Huaier Granule versus SOX regimen in the postoperative adjuvant treatment of resectable stage II-III gastric cancer.
Official title: Effect and Safety of Huaier Granule Versus SOX Regimen for the Prevention of Recurrence/Metastasis After Radical Surgery for Stage II-III Gastric Cancer Patients: a Prospective, Multi-center, Open-label and Randomised Control Study
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
702
Start Date
2024-07-01
Completion Date
2029-11-01
Last Updated
2024-06-24
Healthy Volunteers
No
Conditions
Interventions
Huaier granule
Huaier granule, oral administration, 10g each time, 3 times a day. Continuous medication until disease progression, the end of the study, intolerable toxicity, withdrawal from the study for any reason or death, or until the researcher determines that the participants will no longer benefit, whichever occurs first. After disease progression, whether to continue the medication or not should be determined by the researcher and participant together. Participants will start taking Huaier granule within 1 to 3 weeks after surgery.
Oxaliplatin
Participants will receive intravenous infusion of 130 mg/m² oxaliplatin on the first day of treatment cycle.
Tegafur, Gimeracil and Oteracil Potassium
Participants will receive oral Tegafur, Gimeracil and Oteracil Potassium (40 mg/m², twice a day) for 2 weeks, followed by 1 week of rest.
Locations (2)
Wuhan Union Hospital
Wuhan, Hubei, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China