Gastric adenocarcinoma
Conditions
Interventions
Intervention Group:camrelizumab+ Oxaliplatin + Tegafur
Sponsors
Jiaozuo No.2 People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years; No gender limit; 2. Adenocarcinoma of the gastric and gastroesophageal junction was confirmed by gastroscopic biopsy and histological examination; 3. Stage III patients confirmed by CT/MRI and ultrasound gastroscopy; 4. ECOG score: 0~2; 5. Expected survival >=12 weeks; 6. Who can provide histological specimens for secondary testing; 7. Major organ functions within 7 days prior to treatment shall meet the following criteria: (1) Standard of blood routine examination (without transfusion within 14 days) : hemoglobin (HB) >=90g/L; Neutrophil absolute value (ANC) >=1.5x10^9/L; Platelet (PLT) >=80x10^9/L; (2) Biochemical examination should meet the following criteria: total bilirubin (TBIL) =60ml/min; (3) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) >= the lower limit of normal value (50%); 8. Women of reproductive age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and for six months after the study ends; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be non-lactating; Men should consent to patients who must use contraception during the study period and for 6 months after the study period ends; 9. The patients participated in this study voluntarily and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Present or present with other malignancies within 5 years, except cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basal membrane)]; 2. Patients with a high risk of bleeding or fistula due to significant tumor invasion of adjacent organs (major arteries or trachea); 3. Patients with conditions requiring systemic therapy with corticosteroids (>10 mg daily equivalent of prednisone) or other immunosuppressive agents within 14 days prior to the start of study therapy. In the absence of active autoimmune disease, inhaled or topical steroids with a daily equivalent dose of >10 mg prednisone and adrenal replacement steroid doses are permitted; 4. Those who have received any antitumor therapy in the past; 5. Patients with significant malnutrition. Exclusion is performed if the patient is receiving intravenous nutrient solution or requires hospitalization for continuous infusion therapy. Patients with well-controlled nutrition for >= 28 days before randomization could be enrolled; 6. Patients who received live/attenuated vaccine within 30 days of the first treatment; 7. Unmitigated toxic reactions above CTCAE4.0 level 2 due to any prior treatment, excluding hair loss and oxaliplatin =150 mmHg, diastolic blood pressure >=100 MMHG) who cannot be well controlled by antihypertensive medications; (2) Patients with grade I or above myocardial ischemia or myocardial infarction, arrhythmias (including QTc>=480ms), and >= grade 2 congestive heart failure (New York Heart Association (NYHA) grades); (3) Severe or uncontrolled disease or active infection (>=CTCAE grade 2 infection) that the investigator believes increases the risk associated with study participation, study drug administration, or affects the subject's ability to receive study drugs; (4) Renal failure requiring hemodialysis or peritoneal dialysis; (5) A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; (6) Poor blood glucose control in diabetic patients (fasting blood glucose (FBG) > 10mmol/L); Patients with active, known, or suspected autoimmune diseases. Patients with type I diabetes, residual hypothyroidism due to autoimmune thyroiditis requiring hormone replacement therapy only, or skin conditions that do not require systemic treatment (such as vitiligo, psoriasis, or hair loss) may be included; (7) Patients who have epileptic seizures and need treatment; (8) Patients with a past or current history of interstitial lung disease, pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, or severe impairment of lung function that might interfere with the detection and management of suspected drug-related pulmonary toxicity; (9) Patients with gastrointestinal diseases such as ileus (including incomplete ileus) or who have been determined by researchers to be likely to cause gastrointestinal bleeding, perforation or obstruction; 10. Patients who received surgi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathologic response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathologic complete response;Overall survival;Safety;R0 resection rate; | — |
Countries
China
Contacts
Public ContactQiao Chaofeng
Jiaozuo No.2 People's Hospital
Outcome results
None listed