| Eligibility |
Inclusion Criteria:
1. 18-73 years old; male or female
2. confirmed gastric and gastroesophageal junction adenocarcinoma by Gastroscopic biopsy
histopathological examination
3. Imaging (CT/MRI) and ultrasound gastroscopy confirmed: cT = T2 and / or regional lymph
node positive (N +);
4. ECOG score: 0~2 points;
5. Expected survival period = 12 weeks;
6. A histological specimen can be provided for secondary testing;
7. The main organ function meets the following criteria within 7 days before treatment:
Blood routine examination criteria (without blood transfusion within 14 days):
Hemoglobin (HB) = 90g / L; The absolute value of neutrophils (ANC) = 1.5 × 109 / L;
Platelet (PLT) = 80 × 109 / L (2) Biochemical examinations must meet the following
criteria: Total bilirubin (TBIL) = 1.5 times the upper limit of normal (ULN); Alanine
aminotransferase (ALT) Aspartate aminotransferase (AST) = 2.5 * ULN; serum creatinine
(Cr) = 1.5 * ULN or creatinine clearance (CCr) = 60ml / min; (3) Doppler ultrasound
assessment: left ventricular ejection fraction (LVEF) = normal low limit (50%).
8. Women of childbearing age should agree to use contraceptives (such as intrauterine
devices, contraceptives or condoms) during the study period and within 6 months after
the end of the study; negative serum or urine pregnancy test within 7 days prior to
study enrollment and must be non-lactating patients; men should agree to patients who
must use contraception during the study period and within 6 months after the end of
the study period.
9. The patient volunteered to participate in the study and signed an informed consent
form;
Exclusion Criteria:
1. Exceeding or currently suffering from other malignant tumors within 5 years, except
for cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors
[Ta (non-invasive tumor), Tis (in situ carcinoma) And T1 (tumor infiltrating basement
membrane)];
2. Patients with a high risk of bleeding or fistula due to the apparent invasion of
adjacent organs (aorta or trachea);
3. Before starting treatment, subject administrated corticosteroids (day> 10 mg
equivalent dose prednisone), or other immunosuppressive drugs for systemic treatment
of a disease within 14 days . In the absence of active autoimmune disease, >10 mg of
daily prednisone equivalent dose of inhaled or topical steroid and adrenal replacement
steroid doses are permitted;
4. Anyone who has received any anti-tumor treatment in the past;
5. Significantly malnourished patients. Exclusion is performed if the patient is
receiving intravenous fluids or is required to be hospitalized for continuous infusion
therapy. Patients with good nutrition control = 28 days can be enrolled before
randomization;
6. Participants who received live/attenuated vaccine within 30 days of the first
treatment;
7. Unresolved toxicity due to any previous treatment above CTC AE4.0 Level 2, excluding
neurotoxicity of =2 caused by hair loss and oxaliplatin;
8. Allergic reactions and adverse drug reactions:
1. a history of allergies to the ingredients of the study drug;
2. contraindications to any study drug (fluorouracil or oxaliplatin) in the
chemotherapy regimen.
9. Patients with any severe and/or uncontrolled disease, including:
1. patients with hypertension who are not well controlled by antihypertensive drug
(systolic blood pressure =150 mmHg, diastolic blood pressure =100 mmHg);
2. with grade I or higher myocardial ischemia or myocardial infarction, arrhythmia
(including QTc = 480ms) and = grade 2 congestive heart failure (New York Heart
Association (NYHA) classification);
3. Severe or uncontrolled disease or active infection (=CTCAE grade 2 infection),
which the investigator believes may increase the risk associated with study
participation, study drug administration, or affect the subject's ability to
receive study medication;
4. Renal failure requires hemodialysis or peritoneal dialysis;
5. a history of immunodeficiency, including HIV-positive or other acquired,
congenital immunodeficiency disease, or a history of organ transplantation;
6. Patients with diabetes who have poor glycemic control (fasting blood glucose
(FBG) > 10 mmol/L); subjects with active, known or suspected autoimmune diseases.
Subjects with type 1 diabetes, residual hypothyroidism caused by autoimmune
thyroiditis requiring hormone replacement therapy, and skin diseases that do not
require systemic treatment (such as vitiligo, psoriasis or alopecia) can be
enrolled;
7. patients with seizures and requiring treatment;
8. The subject has an interstitial lung disease that is symptomatic or may interfere
with the discovery or management of suspected drug-related lung toxicity;
previous and current subjects with a history of pulmonary fibrosis, interstitial
pneumonia, pneumoconiosis, radiation pneumonitis, drug-associated pneumonia,
severe impaired lung function, etc. that may interfere with the detection and
management of suspected drug-related lung toxicity;
10. Patients with gastrointestinal diseases such as intestinal obstruction (including
incomplete intestinal obstruction) or those who may have caused gastrointestinal
bleeding, perforation or obstruction;
11. Patients who underwent surgical treatment, incisional biopsy or significant traumatic
injury within 28 days prior to enrollment;
12. In the 4 weeks prior to enrollment, patients with any bleeding event = CTCAE 3 have
unhealed wounds, ulcers or fractures;
13. Overactive/venous thrombosis events within 3 months, such as cerebrovascular accidents
(including transient ischemic attacks), deep static Pulmonary thrombosis and pulmonary
embolism;
14. Prepare or accept previous allogeneic or allogeneic bone marrow transplantation,
including liver transplantation;
15. According to the investigator's judgment, there is a concomitant disease that
seriously harms the patient's safety or affects the patient's completion of the study;
16. Cannot perform biopsy to provide histological specimens;
17. those who have a history of psychotropic substance abuse and are unable to quit or
have a mental disorder; Prepare or accept previous allogeneic or allogeneic bone
marrow transplants, including liver transplants;
18. Urine routine showed urinary protein = 2+ and confirmed 24-hour urine protein
quantitation > 1.0 g;
19. Patients with brain metastases;
20. Patients who have participated in other clinical trials of anti-tumor drugs within
four weeks.
|
