Gastric or gastroesophageal junction adenocarcinoma
Conditions
Interventions
Group A:Apatinib+PD-1 antibody+FLOT
Group B:FLOT+PD-1 antibody
Sponsors
Lanzhou University Second Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Pathologically confirmed adenocarcinoma of the gastric or gastroesophageal junction (G/GEJ); 2. The treatment naïve patient with potential resectable locally advanced G/GEJ adenocarcinoma at a stage of cT3 to cT4, lymph nodes N0-N3, no distant metastasis (M0); 3. Age = 18 years old; 4. Expected survival time = 12 weeks; 5. The Eastern Cooperative Oncology Group performance status of 0 or 1; 6.The include patients have not received any previously treatment against tumors (such as radiotherapy, chemotherapy, targeted therapy or immunotherapy, etc.) 7. The adequate organ function and should meet the following standards: (1) Blood routine (no blood transfusion within 14 days): WBC = 3.0 × 109/L; ANC=1.5 × 109/L; PLT=100 × 109/L;HGB=90 g/L (2) Liver function: AST = 2.5 × ULN (upper limit of normal value); ALT=2.5 × ULN; TBIL=1.5 × ULN; (3) Renal function: Cr = 1.5 × ULN or CrCl = 60 mL/min; (4) Coagulation function: INR = 1.5, APTT = 1.5 × ULN; (5) The adequate cardiac function was assessed by electrocardiogram and color Doppler ultrasound. And the patient not underwent a myocardial infarction attack within six months. Hypertension and other coronary heart diseases can be controlled in the controllable range; 8. There are no other uncontrollable benign diseases such as lung, kidney, and liver infections before enrollment; 9. Sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. The patient with G/GEL adenocarcinoma has any distant metastatic lesions, or has other any other secondary malignant diseases, or the patient is recurrence of adenocarcinoma in the G/GEJ; 2. The medical history and complications: (1) The patient has any known active autoimmune disease (Patients who have stable clinical symptoms and do not need systemic immunosuppressants can be included, such as type I diabetes and hypothyroidism requiring only hormonotherapy, or desmosis not need systemic treatment); (2) The patient who requiring systemic treatment with glucocorticoids such as prednisone (>10mg/day) or who have used immunosuppressive drugs within 14 days before the first administration (such as no active autoimmune disease, inhalation or topical use of glucocorticoids, and use of prednisone (>10mg/day) for hormone replacement therapy for adrenal insufficiency may be included in the group); (3) The patient is participating in another clinical trial; (4) The patient has previously received any anti-tumor treatment, such as surgery, radiotherapy, chemotherapy, immunotherapy, and molecular target therapy; (5) The patient has other malignant tumors. (However, patients with basaloma or squamous cell carcinoma of the skin, or carcinoma in situ of the breast, or carcinoma in situ of the cervix who have received radical treatment and do not require other treatment may be enrolled); (6) The patient previously had severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia (including QTc interval = 480 ms); Grade III to IV cardiac insufficiency; Left ventricular ejection fraction (LVEF)<50% detected by color Doppler echocardiography; (7) The patient has a known history of organ transplantation or Hematopoietic Stem Cell Transplantation; (8) The Patient received living vaccines within 30 days before the first administration; (9) The Patient has other uncontrollable severe diseases (including atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction lower than 50%, renal insufficiency, urinary protein test 2+or more). 3. Severe allergies and adverse drug reactions should be excluded: (1) The Patient is severe allergic to apatinib or other drugs in the treatment plan; (2) Severe allergy or intolerance during infusion. 4. The Patient is suffering from mental illness, alcohol abuse, drug abuse, etc. should be excluded 5. Pregnant or lactating women. 6. The researcher believes that the patient is not suitable for inclusion, may affects the research results, or is not in the interest of the subject, or laboratory indicators that are abnormal should be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response Rate;Overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathological Response Rate;Disease control rate;Disease-free survival;Overall survival rate;Safety;Life quality;Surgical related complications; | — |
Countries
China
Contacts
Public ContactJiao Zuoyi
Lanzhou University Second Hospital
Outcome results
None listed