Actively Recruiting
Shenqi Fuwei Mixture Combined With Chemotherapy Neoadjuvant Therapy for Locally Advanced Gastric Cancer
Led by Hunan Cancer Hospital · Updated on 2025-08-01
286
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Shenqi Fuwei Mixture Combined With Chemotherapy Neoadjuvant Therapy for Locally Advanced Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma by pathology or cytology
- Resectable or potentially resectable gastric cancer with clinical stage cT3-4aN+M0 or cT4bNxM0
- No prior anti-tumor treatments such as chemotherapy, radiotherapy, immunotherapy, or targeted therapy
- Adequate organ function including ANC ≥ 1.5 × 10^9/L, hemoglobin ≥ 9 g/dL, platelets ≥ 80 × 10^9/L, albumin ≥ 30 g/L, serum bilirubin ≤ 1.5 × ULN, AST and ALT ≤ 2.5 × ULN, ALP ≤ 2.5 × ULN, TBIL ≤ 1.5 × ULN, and serum creatinine < 1.5 × ULN
- Karnofsky Performance Status (KPS) score ≥ 70 points
- Male or female aged between 18 and 75 years
- Signed written informed consent voluntarily
You will not qualify if you...
- Presence of distant metastasis
- Known hypersensitivity or metabolic disorder to fluorouracil, oxaliplatin, or the study drug
- Presence of primary malignant tumors at other sites except disease-free for 5 years or history of completely resected non-melanoma skin cancer or treated carcinoma in situ
- Gastrointestinal emergencies such as inability to swallow, gastrointestinal obstruction, bleeding, or perforation
- Pregnancy, neurological diseases, mental illness, or mental and language disorders
- Uncontrolled angina pectoris, arrhythmia, congestive heart failure, myocardial infarction, or cardiac insufficiency within 6 months prior to enrollment
- Any serious concurrent disease or condition that may interfere with safety or study participation
- Persons legally incapable or unsuitable for continuing study treatment for ethical or medical reasons
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
Actively Recruiting
Research Team
B
Bowen Xu, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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