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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
702
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.
Participants will receive intravenous infusion of 130 mg/m² oxaliplatin on the first day of treatment cycle.
Participants will receive oral Tegafur, Gimeracil and Oteracil Potassium (40 mg/m², twice a day) for 2 weeks, followed by 1 week of rest.
Wuhan Union Hospital
Wuhan, Hubei, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
3-year DFS rate
The proportion of patients who does not have recurrence of primary cancer, new gastric cancer, distant metastases (assessed by each investigator), or death from any cause within 3 years after receiving surgery.
Time frame: up to 36-months follow-up
1, 2-year DFS rate
The proportion of patients who do not have recurrence of primary cancer, new gastric cancer, distant metastases (assessed by each investigator), or death from any cause within 1/2 years after receiving surgery.
Time frame: up to 12/24-months follow-up
1, 2, 3-year OS rate
The proportion of patients who will be alive within 1/2/3 years after receiving surgery.
Time frame: up to 12/24/36-months follow-up
1, 2, 3-year local recurrence-free survival rate
The proportion of patients who do not have local recurrence or regional lymph node metastasis from an cause within 1/2/3 years after receiving surgery.
Time frame: up to 12/24/36-months follow-up
1, 2, 3-year distant metastasis-free survival rate
The proportion of patients who do not have distant metastasis from an cause within 1/2/3 years after receiving surgery.
Time frame: up to 12/24/36-months follow-up
Quality of life score
The patients will evaluated by the Short-Form 36 (SF-36) Health Survey (Chinese version), which is a 36-item questionnaire measures health on 8 multi-item dimensions. Scores are computed for each dimension by adding the recorded item responses together and transforming the results onto a scale from 0 (worst health on scale) to 100 (best health on scale).
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Time frame: Up to 36 months since the start of treatment
Incidence and severity of adverse events and serious adverse events
The incidence of adverse events and serious adverse events (referring to CTCAE 5.0 ) will be analyzed.
Time frame: up to 36-months follow-up
Incidence and severity of adverse reactions, serious adverse reactions, suspicious and unexpected serious adverse reactions
The incidence of ADR, SADR and SUSAR (referring to CTCAE 5.0 ) will be analyzed.
Time frame: up to 36-months follow-up