Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Location status: Recruiting
NCT Number: NCT07098026
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
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Changsha, Hunan, 410013, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Shenqi Fuwei Mixture
Shenqi Fuwei Mixture Placebo
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
Event-Free Survival
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
Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 60 months
Overall Survival
Time frame: "Baseline" or "3 week"
CEA、CA724、CA199、CA125
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
Disease-Free Survival
Time frame: Perioperative/Periprocedural
Time frame: "Baseline" or "At the begin of Cycle 1 (each cycle is 21 days)"
Functional Assessment of Cancer Therapy--Gastric cancer Scale. minimum and maximum values: 0-100, and higher scores mean a better outcome.
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Time frame: "Baseline" or "At the begin of Cycle 1 (each cycle is 21 days)"
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)"
M.D.Anderson Symptom Inventory Traditional Chinese Medicine Scale. minimum and maximum values: 0-100, and higher scores mean a better outcome.
Contact information is provided by the study sponsor or research team.
Hunan Cancer Hospital
Other
Shenqi Fuwei Mixture Combined With Chemotherapy Neoadjuvant Therapy for Locally Advanced Gastric Cancer: A Multicenter Randomized Controlled Clinical Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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