| Eligibility |
Inclusion Criteria:
- 18 years old = age = 70 years old, male or female;
- ECOG score 0-1 points;
- Patients with locally advanced gastric cancer confirmed by pathology (histology or
cytology) (according to WHO classification in 2015);
- Nucleic acid test or antigen test to identify patients with COVID-19 infection
- According to the TNM stage of clinical tumor in the 8th edition, T3~4N+M0 gastric
cancer patients confirmed as resectable or potentially resectable by endoscopic
ultrasound and enhanced CT;
- It has measurable lesions (according to RECIST 1.1 standard, the long diameter of CT
scan of tumor lesions is = 10mm, and the short diameter of CT scan of lymph node
lesions is = 15mm;);
- Those who were diagnosed as gastric cancer for the first time before enrollment and
did not undergo radiotherapy, chemotherapy, surgery and targeted treatment;
- The function of main organs is normal, that is, they meet the following standards:
- The blood routine examination must meet the following requirements (no blood
transfusion, no hemopoietic factor and no drug correction within 14 days):
- ANC = 1.5 × 109/L;
- PLT = 100 × 109/L;
- HB = 90 g/L;
- Biochemical examination shall meet the following standards:
- TBIL=1.5 × ULN;
- ALT?AST= 2.5 × ULN
- Serum creatinine sCr = 1.5 × ULN, endogenous creatinine clearance = 50 mL/min
(Cockcroft-Gault formula);
- Coagulation function must meet: INR = 1.5 × ULN and APTT = 1.5 × ULN;
- Female subjects of childbearing age must carry out a serum pregnancy test within 3
days before starting the study medication, and the result is negative, and are willing
to use a medically approved effective contraceptive measure (such as intrauterine
device, contraceptive or condom) during the study period and within 3 months after the
last administration of the study medication; For male subjects whose partners are
women of childbearing age, they should undergo surgical sterilization or agree to use
effective methods of contraception during the study and within 3 months after the last
study administration;
- Subjects voluntarily joined the study and signed the informed consent form, with good
compliance and cooperation in follow-up;
Exclusion criteria:
- Patients with distant metastasis;
- Subjects who have previously received anti-PD-1 (L1) or CTLA4 monoclonal antibodies;
- Medical history and complications
- Other malignant tumors in the past 3 years;
- Have any history of active autoimmune diseases or autoimmune diseases (including but
not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis,
vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included
after hormone replacement therapy); Patients with vitiligo or childhood asthma have
been completely relieved and can be included without any intervention after adulthood;
Patients who need bronchodilator for medical intervention cannot be included;
- Immunosuppressive drugs were used within 14 days before the first use of the study
drug, excluding nasal spray and inhaled corticosteroids or systemic steroid hormones
with physiological dose (i.e. no more than 10 mg/day prednisone or its equivalent);
- Uncontrolled hypertension (systolic blood pressure = 140 mmHg or diastolic blood
pressure = 90 mmHg, despite the best drug treatment);
- Newly diagnosed angina pectoris within 3 months before screening or myocardial
infarction events within 6 months before screening; Arrhythmias (including QTcF: male
= 450 ms, female = 470 ms) require long-term use of antiarrhythmic drugs and cardiac
insufficiency of New York Heart Association grade = II; Or uncontrolled heart failure;
- There is evidence that there is pulmonary fibrosis, interstitial pneumonia,
pneumoconiosis, radiological pneumonia, drug-induced pneumonia and serious damage to
lung function in the past or at present;
- Severe infection (such as the need for intravenous drip of antibiotics, antifungal or
antiviral drugs) occurred within 4 weeks before the first administration, or fever of
unknown cause occurred during screening/before the first administration>38.5 ° C;
- There is clinically significant hemoptysis (more than 50 mL of hemoptysis per day)
within the first three months of the study, or there is clinically obvious bleeding
symptom or obvious bleeding tendency (such as gastrointestinal bleeding, gastric ulcer
bleeding, gastrointestinal bleeding, hemorrhagic gastric ulcer, stool occult blood++or
above the baseline, or suffering from vasculitis).
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem
cell transplantation;
- Inoculate live attenuated vaccine within 4 weeks before the first administration or
during the study period;
- Physical examination and laboratory examination findings
- People with congenital or acquired immune deficiency, such as people infected with
human immunodeficiency virus (HIV), active hepatitis B (HBV DNA = 500 IU/mL),
hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the detection
limit of the analytical method) or combined with hepatitis B and hepatitis C
infection;
- Pregnant or lactating women; Those with fertility who are unwilling or unable to take
effective contraceptive measures;
- Known to have a positive history of human immunodeficiency virus (HIV) test or known
to have acquired immunodeficiency syndrome (AIDS);
- Allergic reactions, allergic reactions and adverse drug reactions
- Severe allergic reaction to other monoclonal antibodies;
- Allergy or intolerance to infusion;
- Have a history of severe allergy to arotinib or its preventive drugs;
- Subjects who are participating in other clinical studies or whose first medication is
less than 4 weeks from the end of the previous clinical study (the last medication),
or who have 5 half-lives of the study drug;
- Subjects are known to have a history of abuse of psychotropic substances, alcohol
abuse or drug abuse;
- The researcher believes that there are any conditions that may damage the subject or
cause the subject to fail to meet or perform the research requirements
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