Gastric Cancer, Adenocarcinoma
Conditions
Keywords
locally advanced gastric cancer, perioperative, neoadjuvant chemotherapy, Shenqi Fuwei Mixture
Brief summary
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
Interventions
DRUGShenqi Fuwei Mixture
Shenqi Fuwei Mixture
DRUGShenqi Fuwei Mixture Placebo
Shenqi Fuwei Mixture Placebo
Sponsors
Hunan Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Subjects, investigators, image assessors, and statistical analysts were blinded and emergency letters were set up to unblind.
Intervention model description
Multicenter, large-sample, randomized, double-blind, placebo-controlled clinical study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Gastric or gastroesophageal junction adenocarcinoma confirmed by pathology or cytology; * Resectable or potentially resectable gastric cancer with clinical stage of cT3-4aN + M0 or cT4bNxM0; * Patients who are not allowed to receive previous anti-tumor therapy including chemotherapy radiotherapy immunotherapy or targeted therapy; 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. * KPS ≥ 70 points; * 18-75 years old male or female; * Subjects voluntarily signed a written informed consent form.
Exclusion criteria
* Associated with distant metastasis; * Patients with known hypersensitivity or metabolic disorder to fluorouracil or oxaliplatin or known hypersensitivity or intolerance to the study drug; 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; * Gastrointestinal emergencies include: inability to swallow (complete or incomplete) gastrointestinal obstruction gastrointestinal bleeding and gastrointestinal perforation; * Patients who are pregnant have neurological diseases or mental illness and mental and language disorders; * Known uncontrolled angina pectoris arrhythmia congestive heart failure or myocardial infarction or a history of cardiac insufficiency within 6 months prior to study enrollment; * 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; * Persons who are incapable (legally) or unsuitable for continuing study treatment for ethical/medical reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EFS | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | From date of randomization until the date of death from any cause, whichever came first, assessed up to 60 months | Overall Survival |
| Tumor markers | Baseline or 3 week | CEA、CA724、CA199、CA125 |
| DFS | 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 |
| Infections and complications | Perioperative/Periprocedural | — |
| Surgical conversion rate | Binary classification variables were used to calculate the proportion of patients who could undergo surgery, whichever came first, assessed up to 60 months | — |
| Adverse events | At the end of Cycle 1 (each cycle is 21 days) | — |
| ESAS Scale | 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. |
| MDASI-TCM Scale | 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. |
| FACT-Ga Scale | 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. |
Countries
China
Contacts
Primary ContactBowen Xu, Dr.
Outcome results
None listed