The purpose of this clinical trial is to investigate whether the drug Shenqi Fuwei Mixture is effective for postoperative recurrence and metastasis of gastric cancer. Safety of Shenqi Fuwei Mixture will also be understood. It aims to answer the main questions: * Shenqi Fuwei Mixture in perioperative combined with neoadjuvant chemotherapy to reduce the recurrence and metastasis of locally advanced gastric cancer after surgery? * Shenqi Fuwei Mixture in the prevention and treatment of postoperative recurrence and metastasis of gastric cancer dominant population characteristics and efficacy mechanism? * Exploratory excavation of TCM syndrome, multi-omics combined means to explore the advantages of Shenqi Fuwei Mixture on postoperative recurrence and metastasis of gastric cancer? The researchers will compare the drug Shenqi Fuwei Mixture with placebo (a substance that does not contain drugs and has a similar appearance) to see if the drug Shenqi Fuwei Mixture can prevent and treat recurrence and metastasis of gastric cancer after surgery. Participants will: * Take Shenqi Fuwei Mixture or placebo daily, synchronize with chemotherapy, or until tumor progression or intolerable toxicity * Visits every 3 weeks for tests and tests * Their survival status and adverse drug reactions were recorded
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
286
Shenqi Fuwei Mixture
Shenqi Fuwei Mixture Placebo
Hunan Cancer Hospital
Changsha, Hunan, China
RECRUITINGEFS
Event-Free Survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Surgical conversion rate
Time frame: Binary classification variables were used to calculate the proportion of patients who could undergo surgery, whichever came first, assessed up to 60 months
OS
Overall Survival
Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 60 months
Tumor markers
CEA、CA724、CA199、CA125
Time frame: "Baseline" or "3 week"
DFS
Disease-Free Survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Infections and complications
Time frame: Perioperative/Periprocedural
FACT-Ga Scale
Functional Assessment of Cancer Therapy--Gastric cancer Scale. minimum and maximum values: 0-100, and higher scores mean a better outcome.
Time frame: "Baseline" or "At the begin of Cycle 1 (each cycle is 21 days)"
Adverse events
Time frame: At the end of Cycle 1 (each cycle is 21 days)
ESAS Scale
Edmonton Symptom Assessment Scale. minimum and maximum values: 0-100, and higher scores mean a better outcome.
Time frame: "Baseline" or "At the begin of Cycle 1 (each cycle is 21 days)"
MDASI-TCM Scale
M.D.Anderson Symptom Inventory Traditional Chinese Medicine Scale. minimum and maximum values: 0-100, and higher scores mean a better outcome.
Time frame: "Baseline" or "At the begin of Cycle 1 (each cycle is 21 days)"
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