Gastric or gastroesophageal junction adenocarcinoma
Conditions
Interventions
Treatment group:AK104+ FLOT
Sponsors
Lanzhou University Second Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Pathological diagnosis of adenocarcinoma of the stomach or gastroesophageal junction; 2. Oncological evaluation of initial treatment of locally advanced gastric cancer patients who can be radically resected (clinical stage: cT3 to cT4, lymph node N1-N3, no distant metastasis (M0)); 3. Aged 18-75; 4. Expected survival time >= 12 weeks 5. Physical condition: 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) The ECG and color Doppler ultrasound showed no obvious abnormality. Before enrollment, the heart function was good. There was no myocardial infarction within six months. Hypertension and other coronary heart diseases were currently within the controllable range; 8. There are no other uncontrollable benign diseases such as lung, kidney and liver infection before enrollment; 9. Sign the informed consent form.
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;Major response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate;Disease control rate;Disease-free survival;Overall survival rate;Safety; | — |
Countries
China
Contacts
Public ContactZuoyi Jiao
Lanzhou University Second Hospital
Outcome results
None listed