| Eligibility |
Inclusion Criteria:
- 18 years old = age = 70 years old, male or female;
- ECOG score 0~1 points;
- Patients with locally advanced gastric cancer (according to WHO 2015 classification)
confirmed by pathology (histology or cytology);
- According to the eighth edition of clinical tumor TNM staging, patients with T3~4N+M0
gastric cancer confirmed by endoscopic ultrasonography and enhanced CT examination as
resectable or potentially resectable;
- With measurable lesions (according to RECIST 1.1 criteria, the long diameter of CT
scan of tumor lesions is =10mm, and the short diameter of CT scan of lymph node
lesions is =15mm;), tumor diameter > 2cm;
- Those who were diagnosed with gastric cancer for the first time before enrolling in
the group and who have not undergone radiotherapy, chemotherapy, surgery and targeted
therapy;
1. Major organ function is normal, that is, the following criteria are met:
2. Routine blood tests must meet (no blood transfusion, no hematopoietic factor and
no drug correction within 14 days):
1. ANC = 1.5×109/L;
2. PLT = 100×109/L;
3. HB = 90 g/L;
3. Biochemical tests must meet the following criteria:
1. TBIL=1.5×ULN;
2. ALT?AST= 2.5×ULN
3. serum creatinines Cr=1.5×ULN,endogenous creatinine clearance=50
mL/min(Cockcroft-Gault formula);
- Coagulation function must meet the following criteria:INR=1.5×ULN;APTT=1.5×ULN;
Patients with myocardial ischemia or myocardial infarction above grade 1, arrhythmia
(including QTc=450ms (male), QTc=470ms (female)) and = grade 2 congestive heart
failure (New York Heart Association (NYHA) classification);
- Female subjects of childbearing potential must have a negative serum pregnancy test
within 3 days before starting the study drug, and be willing to use a
medically-approved high-efficiency contraceptive during the study and within 3 months
after the last dose of study drug ( Such as: intrauterine device, contraceptive pill
or condom); for male subjects whose partner is a female of childbearing age, surgical
sterilization, or agree to use an effective method during the study and within 3
months after the last study dose contraception;
- The subjects voluntarily joined the study, signed the informed consent form, had good
compliance, and cooperated with the follow-up;
Exclusion Criteria:
- Target disease exclusion criteria
1. Patients with distant metastasis;
2. Subjects who have previously received anti-PD-1 (L1) or CTLA4 monoclonal antibody
therapy;
- Medical history and comorbidities
1. Suffering from other malignant tumors in the past 3 years;
2. Suffering from any active autoimmune disease or history of autoimmune disease (as
follows, but not limited to: interstitial pneumonia, uveitis, enteritis,
hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism,
Hypothyroidism (may be included after hormone replacement therapy); patients with
vitiligo or complete remission of childhood asthma who do not require any
intervention in adulthood may be included; patients requiring medical
intervention with bronchodilators are not included;
3. The use of immunosuppressive drugs within 14 days before the first use of the
study drug, excluding nasal and inhaled corticosteroids or systemic steroids at
physiological doses (ie, no more than 10 mg/day prednisone or its equivalent) );
4. Uncontrolled hypertension (systolic blood pressure =140 mmHg or diastolic blood
pressure =90 mmHg despite optimal medical therapy);
5. Patients with newly diagnosed angina pectoris within 3 months before screening or
myocardial infarction events within 6 months before screening; arrhythmia
(including QTcF: =450 ms for males, =470 ms for females) requires long-term use
of antiarrhythmic drugs and New York Cardiac Association classification = class
II cardiac insufficiency; or uncontrolled heart failure;
6. There is evidence of past or current pulmonary fibrosis, interstitial pneumonia,
pneumoconiosis, radiological pneumonia, drug-induced pneumonia, and severely
impaired lung function;
7. Complicated severe infection within 4 weeks before the first dose (eg: need for
intravenous infusion of antibiotics, antifungal or antiviral drugs), or
unexplained fever >38.5°C during the screening period/before the first dose;
8. Clinically significant hemoptysis (more than 50 mL of hemoptysis per day) within
3 months before the study, or clinically significant bleeding symptoms or obvious
bleeding tendency (such as gastrointestinal bleeding, gastric ulcer bleeding,
gastrointestinal bleeding, hemorrhagic Gastric ulcer, fecal occult blood++ or
above baseline, or suffering from vasculitis, etc.).
9. Known history of allogeneic organ transplantation or allogeneic hematopoietic
stem cell transplantation;
10. Administer live attenuated vaccines within 4 weeks before the first dose or
during the study period;
- Physical examination and laboratory findings
1. Patients with congenital or acquired immunodeficiency, such as human
immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA = 500 IU/mL),
hepatitis C (positive hepatitis C antibody, and high HCV-RNA) (the lower limit of
detection of the analytical method) or co-infection with hepatitis B and C;
2. Pregnant or breastfeeding women; patients with childbearing potential who are
unwilling or unable to take effective contraceptive measures;
3. Known positive history of human immunodeficiency virus (HIV) or known acquired
immunodeficiency syndrome (AIDS);
- Allergies, anaphylaxis and adverse drug reactions
1. Severe allergic reactions to other monoclonal antibodies;
2. Allergy or intolerance to infusion;
3. Have a history of severe allergy to Anlotinib or its preventive medicines;
- Subjects who are participating in other clinical studies or whose first dose is less
than 4 weeks from the end of the previous clinical study (last dose), or 5 half-lives
of the research drug;
- The subject is known to have a history of psychotropic substance abuse, alcohol or
drug abuse;
- The investigator believes that there are any conditions that may harm the subject or
prevent the subject from meeting or performing the research requirements.
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