Gastric or gastroesophageal junction adenocarcinoma
Conditions
Interventions
Experimental Group:Chemotherapy + Immune checkpoint inhibitor + Statin
Sponsors
Lanzhou University Second Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Gastric or esophagogastric junction adenocarcinoma confirmed by pathology; 2. Patients with locally advanced gastric cancer (clinical stage: cT2 to cT4, lymph node N0-N3, no distant metastasis (M0)) that could be radically resectable according to the initial oncology evaluation; 3. Aged 18-75 years old; 4. Expected survival time >=12 weeks; 5. Physical status: ECOG 3.0×10^9/L; ANC>=1.5×10^9/L; PLT>=100×10^9/L; HGB>=90 g/L (2) Liver function: AST=60 mL/min; (4) Coagulation function: INR<=1.5, APTT<=1.5×ULN; (5) There were no obvious abnormalities in electrocardiogram and echocardiography. Before enrollment, the heart function was good, there was no myocardial infarction within half a year, and hypertension and other coronary heart disease were currently within the controllable range. 8. No other uncontrollable benign diseases such as lung, kidney, liver infection before enrollment; 9. Sign informed consent.
Exclusion criteria
Exclusion criteria: 1. The patient had distant metastasis of adenocarcinoma in the stomach or gastroesophageal junction that could not be radically removed, or had recurrence of adenocarcinoma in the stomach or gastroesophageal junction; Or other malignant secondary diseases; 2. Medical history and complications: (1) Subjects with any known active autoimmune disease (subjects who have stable clinical symptoms and do not need systemic immunosuppressants, such as type I diabetes and hypothyroidism requiring hormone therapy only, and skin diseases that do not need systemic treatment can be included); (2) Subjects who have any complications requiring systemic treatment with glucocorticoids such as prednisone (>10mg/day) or who have used immunosuppressive drugs within 14 days before the first administration (subjects who have no active autoimmune diseases, inhaled or locally used glucocorticoids, and who have used prednisone (>10mg/day) for hormone replacement treatment of adrenal insufficiency can be included in the group); (3) Subjects received tumor vaccine or other immunoactive anti-tumor drugs (such as interferon, interleukin, thymosin or immunocyte therapy) within 1 month before the first administration; (4) Subjects are participating in other clinical trials; (5) Subjects have received surgery, radiotherapy, chemotherapy and other anti-tumor treatments in the past; (6) Subjects with other malignant tumors that need to be treated (subjects with skin basal cell carcinoma, skin squamous cell carcinoma, breast cancer in situ or cervical cancer in situ that have received radical treatment and do not need other treatment can be included); (7) Subjects had serious cardiovascular diseases in the past: myocardial ischemia or myocardial infarction above Grade II, arrhythmia with poor control (including QTc interval >= 480 ms); Grade III-IV cardiac insufficiency; Color Doppler echocardiography showed that left ventricular ejection fraction (LVEF)<50%; (8) Subjects had known history of allogeneic organ transplantation and allogeneic hematopoietic hepatocyte transplantation; (9) Subjects received live vaccine within 30 days before the first administration; (10) Subjects also have other serious diseases that are difficult to control (including atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction less than 50%, renal insufficiency, urinary protein detection 2+or more); 3. Allergies and adverse drug reactions should be excluded: (1) People who are allergic to apatinib or other drugs in the treatment plan. Allergy or hypersensitivity; (2) Severe allergy or intolerance during infusion; 4. Subjects suffering from mental illness, alcohol abuse, drug abuse, etc. should be excluded; 5. Pregnant or lactating women; 6. Diseases or abnormal laboratory indicators that the investigator thinks are not suitable for the inclusion and will affect the research results, or do not conform to the interests of the subject should be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response;Disease control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major response rate;Overall response rate;Disease-free survival;Overall survival rate;Safety; | — |
Countries
China
Contacts
Public ContactZeyuan Yu
Lanzhou University Second Hospital
Outcome results
None listed