| Eligibility |
Inclusion Criteria:
- Age: 18-85 years of age
- Gastric adenocarcinoma was confirmed by pathology# including histology or cytology##
- CT/MRI,PET-CT or laparoscopic exploration were used to confirm the diagnosis of
gastric cancer staging as cT2-4a and/or N+ and M0 before operation.
- measurable lesions at least should be detected by CT/MRI examination in accordance
with the RECIST1.1.#CT scan of tumor lesion length=10mm#CT scan short
diameter=15mm#scan slice thicknes 5mm#
- ECOG#Eastern Cooperative Oncology Group#PS#Performance Status#:0-1 scores;
- the expected survival time is more than 12 weeks
- the main organ function is normal, which should meet the following criteria:
(1) blood routine examination standards should be met#no blood transfusion within 14
days#
a#HB= 100g/L b. WBC=3×109/L c. ANC=1.5×109/L d. PLT=100×109/L #2#biochemical
examination shall comply with the following criteria#
1. BIL#1.5 normal upper limit ULN
2. ALT and AST#2.5 ULN,GPT=1.5×ULN
3. Cr=1 ULN#CCR#creatinine clearance rate#60ml/min(Cockcroft Gault formula)
- women of childbearing age must have a pregnancy test in 7 days before entering the
group (in serum), and the results were negative, and willing to use appropriate
contraception during the study period and the last 8 weeks after giving drug test; men
should have the surgical sterilization, or adopt the appropriate contraceptive methods
during the test and the last 8 weeks after giving drug test#
- No other clinical studies were conducted before and during the treatment
- participants is willing to participate in this study, sign the informed consent, have
good compliance, cooperate with follow-up.
Exclusion Criteria:
- Previous history of chemotherapy, radiotherapy, targeted drug therapy or immunotherapy
- Patients with contraindications for surgical treatment and chemotherapy or whose
physical condition and organ function do not allow for larger abdominal surgery
- patients with metastasis
- Having any active autoimmune diseases or a history of autoimmune diseases (such as
interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation,
vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism, including but not
limited to these diseases or syndromes); Patients with vitiligo or cured childhood
asthma/allergies who did not need any intervention in adulthood were excluded;
Autoimmune hypothyroidism treated with a stable dose of thyroid replacement hormone;
Type 1 diabetes with stable doses of insulin
- A history of immunodeficiency, including HIV testing positive, or other acquired or
congenital immunodeficiency disorders, or a history of organ transplantation and
allogeneic bone marrow transplantation
- Accompanied by serious heart, lung, liver, kidney disease; Have nerve, mental disease;
Jaundice or obstruction of the digestive tract with severe infection
- pregnant or lactating women
- The blood pressure of patients with hypertension cannot be reduced to the normal range
by the antihypertensive drugs (systolic pressure >140 mmHg, diastolic pressure >90
mmHg)
- With # magnitude of coronary heart disease, arrhythmia (including QTc protracted
between male > 450 ms, women > 470 ms) and cardiac insufficiency
- Patients have a clear tendency with gastrointestinal bleeding, including the following
situation: local active ulcerative lesions, and fecal occult blood (+ +); with melena
and hematemesis history in 2 months; and patients with fecal occult blood (+) and
unresected gastric primary tumor; patients with the risk of bleeding should take the
gastroscopy test, if it is the gastric cancer, and researchers believe that may
results in massive digestive tract hemorrhage#coagulation dysfunction
(INR(international normalized ratio)>1.5, APTT(activated partial thromboplastin
time)>1.5 ULN), with bleeding tendency;
- Subjects have failed to control good cardiovascular clinical symptoms or disease,
including but not limited to: such as: (1) the NYHA class II heart failure (2) above
unstable angina pectoris (3) occurred within 1 year (4) have clinical significance of
myocardial infarction (mi) room sex or ventricular arrhythmias without clinical
intervention on or after clinical intervention is still poorly controlled
- History of interstitial lung disease (except radiation pneumonia without hormone
therapy), and history of non-infectious pneumonia
- Patients are positive of urine protein (urine protein detection 2+ or above, or 24
hours urine protein quantitative >1.0g);
- A person who has previously been allergic to any component of camrilizumab or to any
component of the drug under study
- The researchers consider those who were not suitable for inclusion.
|
