Gastric carcinoma
Conditions
Interventions
Experimental group:camrelizumab+SOX
Control group:camrelizumab+SOX +trastuzumab
Sponsors
He'nan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years; No gender limit. 2. Gastroscopic biopsy and histological examination confirmed adenocarcinoma of the gastric and gastroesophageal junction. 3. Imaging (CT/MRI) and ultrasonic gastroscopy confirmed: cT>=T2 and/or positive regional lymph nodes (N+). 4. If HER-2 is positive, the test result is IHC3+ or IHC2+/FISH+, and the scoring standard of HER-2 test is referred to the guidelines for detection of gastric cancer HER-2. 5. ECOG score: 0~1. 6. Expected survival >= 12 weeks. 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) >=90 g/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) =60 ml/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 six 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 distant metastases that cannot be surgically resected; 3. Have a history of mental illness or psychotropic substance abuse; 4. 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; 5. Those who have received any antitumor therapy in the past; 6. Patients who received live/attenuated vaccine within 30 days; 7. Allergic reactions and adverse drug reactions: (1) History of allergy to the ingredients of the investigational drug; (2) Contraindications of any investigational drug (oxaliplatin or Tiggio) in chemotherapy regimens; 8. Patients with any severe and/or uncontrolled medical condition, including: (1) Patients with hypertension (systolic blood pressure >=180 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>=480 ms), and >= grade 2 congestive heart failure (NYHA rating); (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; 9. Patients with a large amount of ascites or poorly controlled ascites; 10. Preparing for or having previously received allogeneic organ or bone marrow transplantation, including liver transplantation; 11. Patients with brain metastases; 12. Patients deemed unfit to participate according to the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;Main pathological remission rate;Disease free survival;Overall survival time;Quality of life score; | — |
Countries
China
Contacts
Public ContactLiu Ying
He'nan Cancer Hospital
Outcome results
None listed