Gastric cancer
Conditions
Interventions
Test Group:Shenqi Fuwei Mixture
Control Group:Shenqi Fuwei Mixture Placebo
Sponsors
HuNan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Gastric or gastroesophageal junction adenocarcinoma confirmed by pathology or cytology; 2) Resectable or potentially resectable gastric cancer with clinical stage of cT3-4aN + M0 or cT4bNxM0; 3) Patients who are not allowed to receive previous anti-tumor therapy including chemotherapy radiotherapy immunotherapy or targeted therapy; 4) Adequate organ function defined as follows: hematological 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 renal serum creatinine < 1.5 × ULN. 5) KPS = 70 points; 6) 18-75 years old male or female; 7) Subjects voluntarily signed a written informed consent form.
Exclusion criteria
Exclusion criteria: 1) Associated with distant metastasis; 2) Patients with known hypersensitivity or metabolic disorder to fluorouracil or oxaliplatin or known hypersensitivity or intolerance to the study drug; 3) Patients with primary malignant tumors at other sites. Subjects who were disease-free for 5 years or had a history of completely resected non-melanoma skin cancer or successfully treated carcinoma in situ were eligible; 4) Gastrointestinal emergencies include: inability to swallow (complete or incomplete) gastrointestinal obstruction gastrointestinal bleeding and gastrointestinal perforation; 5) Patients who are pregnant have neurological diseases or mental illness and mental and language disorders; 6) Known uncontrolled angina pectoris arrhythmia congestive heart failure or myocardial infarction or a history of cardiac insufficiency within 6 months prior to study enrollment; 7) Any concurrent disease or condition that may make the subject unsuitable for study participation or any serious medical condition that may interfere with the subject 's safety; 8) Persons who are incapable (legally) or unsuitable for continuing study treatment for ethical/medical reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year DFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical conversion rate;Tumor markers;OS;DFS;Infections and complications;Chemotherapy completion rate;Quality of life symptom evaluation and TCM syndrome score;Immune-related indicators; | — |
Countries
China
Contacts
Public ContactDongfang Li
HuNan Cancer Hospital
Outcome results
None listed