Locally advanced gastric cancer
Conditions
Interventions
Sponsors
The Second Affiliated Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with gastric cancer confirmed by histopathology at the time of initial treatment; 2. According to AJCC 8th Edition, ctnm was diagnosed as ct3-4 n + M0 according to endoscopic ultrasonography or enhanced CT / MRI, and the lesions could be resected; 3. Patients who had not received surgical treatment before did not receive anti-tumor chemoradiotherapy / immunotherapy; 4. ECoG score was 0-1; 5. Patients with an expected survival time of more than 3 months; 6. The injury caused by other treatment has recovered, and the wound has healed completely after receiving drugs or surgery related to other diseases for more than 4 weeks; 7. Subjects should not have received anti-PD-1 or PD-L1 or CTLA-4 or car-t immunotherapy; 8. There was no significant abnormality in routine laboratory examination (blood routine, liver and kidney function, coagulation function, etc.) (1) The blood routine examination standard should meet (no blood transfusion and blood products within 14 days) ANC >= 1.5 * 10^9/L PLT >= 80 * 10^9/L (2) Biochemical examination should meet the following standards: TBIL 45 ml / min (Cockcroft Gault formula); 9. Patients with potential fertility need to use a medically approved contraceptive method (such as intrauterine device, contraceptive or condom) during the study treatment period and within 1 month after the end of the study treatment period, and the serum or urine HCG test must be negative within 72 hours before the study enrollment, and must be in non lactation period; 10. 18-80 years old patients; 11. The subjects volunteered to join the study and signed the informed consent. They had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with distant metastasis and unresectable resection; 2. Patients with other malignant tumors (repeated cancer) within five years; 3. Patients with a history of allergy to any component of the drug used in the trial; 4. The intractable pleural effusion or pericardial effusion was not well controlled; 5. Patients who have previously received anti-PD-1 or PD-L1 or CTLA-4 or car-t immunotherapy; 6. Patients with history of interstitial lung disease (except radiation pneumonia without hormone therapy) and non infectious pneumonia; Seven Patients with any active autoimmune disease or history of autoimmune diseases (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma in childhood have been completely relieved, and do not need any intervention in adulthood Patients with asthma who could not be included in the study could not be included in the study; 8. The subjects were using immunosuppressive agents, or systemic or absorbable local hormone therapy to achieve the purpose of immunosuppression (dosage > 10mg / D, prednisone or other effective hormones), and continued to use them within 2 weeks before enrollment; 9. Patients with severe infection (CTCAE > Level 2) 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infection complications, etc. requiring hospitalization; baseline chest imaging examination revealed active pulmonary inflammation, symptoms and signs of infection 2 weeks before the first use of study drug, or need oral and intravenous antibiotic treatment, except for preventive measures The use of antibiotics; 10. Patients with acute cardiovascular and cerebrovascular diseases, such as acute cerebral infarction and acute coronary syndrome, have not been well controlled; 11. According to NYHA standard, grade III-IV cardiac insufficiency, or left ventricular ejection fraction (LVEF) less than 50% indicated by echocardiography; 12. Patients with definite gastrointestinal bleeding tendency include the following conditions: Patients with local active ulcer lesions and fecal occult blood {(+ +); patients with history of melena and hematemesis within 2 months; 13. Patients with abnormal coagulation function (INR > 1.5 APTT > 1.5 ULN) had bleeding tendency; 14. Patients with long-term uncured wound or fracture; major surgical operation or severe traumatic injury, fracture or ulcer within 4 weeks; 15. Subjects with congenital or acquired immune deficiency (e.g. HIV infected person), or active hepatitis (reference for hepatitis B: HBV DNA test value exceeding the upper limit of normal value; hepatitis C reference: HCV virus titer or RNA detection value exceeding the upper limit of normal value); 16. Patients with a history of psychotropic substance abuse and unable to quit or with mental disorders; The patient's or the patient's serious harm to the safety of the study; 18. The researchers think it is not suitable to be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MPR; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 Resection rate;OS;RFS;QoL; | — |
Countries
China
Contacts
Public ContactYinlu Ding
The Second Hospital of Shandong University
Outcome results
None listed