NCT05498766

Effect and Safety of Huaier Granule Versus SOX Regimen in Gastric Cancer Patients

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 702 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Gastric cancer (GC) is the second most frequently diagnosed cancer and the second leading cause of cancer related deaths in China. China has a higher mortality/incidence ratio (0.845). For stage II-III GC patients, the current standard treatment is D2 gastrectomy followed by adjuvant chemotherapy. Studies showed the 5-year survival rate of early GC is nearly 95%, while the 1-year recurrence and metastasis rate after surgery is about 50%, and the rate of 2-year is as high as 70%. Although adjuvant chemotherapy can prevent recurrence, it is inevitable to the appearance of toxic and side effects, which seriously affect the prognosis and quality of life. Traditional Chinese medicine plays a unique role in enhancement of immune function, detoxification, and synergism of chemoradiotherapy. Huaier granule is an extract from a medicinal fungus. Previous studies have shown that Huaier granule can inhibit the proliferation, angiogenesis, metastasis and invasion of cancer cells, and can reverse the resistance of targeted drugs. Previous studies demonstrated Huaier granule is benefit to resistance to recurrence and metastasis, prolongation of patients' survival, and improvement of quality of life. In this study, about 30 research centers will participate. Total of 702 participants will be divided into two groups (the Huaier group and the control group) at a ratio of 1:1. The Huaier group will receive Huaier granule as postoperative adjuvant therapy, and the control group will receive SOX regimen. The planned length of patient recruitment enrolment will be 2 years and the total length of visits be 3 years. After enrollment, participants will be visited every 12 weeks (window period ± 14 days) until the end of the study or until the patient withdraws from the study for any reason or dies.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	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.
DRUG	Oxaliplatin	Participants will receive intravenous infusion of 130 mg/m² oxaliplatin on the first day of treatment cycle.
DRUG	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.

Timeline

• Start date: 2024-07-01
• Primary completion: 2029-07-01
• Completion: 2029-11-01
• First posted: 2022-08-12
• Last updated: 2024-06-24

Locations

2 sites across 1 country: China