locally advanced gastric/gastroesophageal junction adenocarcinoma
Conditions
Interventions
Group A:SOX and Sintilimab regimen in proximal gastric cancer
Group B:SOX and Sintilimab regimen in distal gastric cancer
Sponsors
Second Hospital of Lanzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically diagnosed as gastric or gastroesophageal junction adenocarcinoma; 2. Patients with locally advanced gastric cancer who can be potentially curatively resected according to oncological assessment in the initial treatment (clinical stage: cT3 to cT4b, lymph nodes N1-N3, no distant metastasis (M0)); 3. The age is 18-75 years old; 4. Expected survival time >= 12 weeks; 5. Physical status: ECOG = 3.0 x 10^9/L; ANC >= 1.5 x 10^9/L; PLT >= 100 x 10^9/L; HGB >= 90 g/L; (2) Liver function: AST = 60 mL/min; (4) Coagulation function: INR <= 1.5, APTT <= 1.5 x ULN; (5) There is no obvious abnormality in the electrocardiogram and color Doppler ultrasound of the heart, the heart function is good before enrollment, there is no myocardial infarction within half a year, and the hypertension and other coronary heart diseases are currently within the controllable range; 8. No other uncontrollable benign diseases such as lung, kidney, liver infection, etc. before enrollment; 9. Sign the informed consent form
Exclusion criteria
Exclusion criteria: 1. Patients with distant metastasis of gastric or gastroesophageal junction adenocarcinoma cannot be curatively resected or recurrence of gastric or gastroesophageal junction adenocarcinoma; or other malignant secondary diseases; 2. Medical history and complications: (1) The subject has any known active autoimmune disease (the subject has stable clinical symptoms and does not require systemic immunosuppressants, such as type I diabetes and hypothyroidism that only require hormone therapy, and does not require systemic immunosuppressants; Treated skin diseases can be included in the group); (2) The subject has any complications requiring systemic treatment with glucocorticoids such as prednisone ( > 10 mg/day) or has used immunosuppressive drugs within 14 days before the first administration (if there is no active autoimmune disease, inhaled Or topical glucocorticoids, and prednisone ( > 10 mg/day) for hormone replacement to treat adrenal insufficiency subjects can be enrolled); (3) Subjects have received tumor vaccines or other immune-activating anti-tumor drugs (such as interferon, interleukin, thymosin or immune cell therapy) within one month before the first administration; (4) Subjects are participating in other clinical trials; (5) Subjects have previously received anti-tumor treatments such as surgery, radiotherapy, and chemotherapy; (6) The subject has other malignant tumors that need treatment (Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the breast or carcinoma in situ of the cervix who have received radical treatment and do not need other treatment can be enrolled) ; (7) Subjects have suffered from severe cardiovascular diseases in the past: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia (including QTc interval >= 480 ms); grade III-IV cardiac insufficiency; cardiac color Doppler ultrasound examination Prompt left ventricular ejection fraction (LVEF) < 50%; (8) The subject has a known history of allogeneic organ transplantation and allogeneic hematopoietic hepatocyte transplantation; (9) The subject has received a live vaccine within 30 days before the first administration; (10) The subject also has other serious diseases that are difficult to control (including atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction lower than 50%, renal insufficiency, urine protein detection of 2+ or above, etc.); 3. Allergies and adverse drug reactions should be excluded; (1) Those who are allergic to Sindilizumab or other drugs in the treatment plan: allergic or hypersensitivity reactions; (2) Severe allergy or intolerance occurs during the infusion; 4. Subjects suffering from mental illness, alcoholism, drug abuse, etc. should be excluded; 5. Pregnant or lactating women; 6. The investigator believes that the unsuitable subjects will affect the research results, or the diseases or abnormal laboratory indicators that are not in the interests of the subjects should be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Disease-free survival;Major pathological response rate;3-year overall survival rate;5-year overall survival rate;safety; | — |
Countries
China
Contacts
Public ContactZeyuan Yu
The Second Hospital of Lanzhou University
Outcome results
None listed