| Eligibility |
Inclusion Criteria:
- Age: 18 years = Age = 75 years;
- Locally advanced or metastatic HER2 negative gastric or gastroesophageal junction
adenocarcinoma confirmed by histopathology or cytology that cannot be resected;
- Has not received radiotherapy, chemotherapy, targeted therapy, or immunotherapy as the
primary treatment option for advanced or metastatic diseases in the past; Participants
with gastric or gastroesophageal junction adenocarcinoma who have previously received
adjuvant or neoadjuvant chemotherapy, radiotherapy, and/or radiochemotherapy are
eligible for enrollment as long as the last administration of the previous protocol
occurred at least 6 months prior to randomization.
- At least one measurable lesion #see Appendix 2#;
- ECOG PS: 0-1 points #see Appendix 4#;
- Estimated survival time>3 months;
- The main organ function is normal and meets the following criteria:
- Blood routine examination must meet the following criteria#no blood transfusion within
14 days#
1. HB = 100g/L,
2. WBC = 3 × 109/L
3. ANC = 1.5 × 109/L,
4. PLT = 100 × 109/L;
- Biochemical examination must meet the following standards:
1. BIL<1.5 times the upper limit of normal value #ULN#,
2. ALT and AST<2.5ULN, GPT = 1.5 × ULN;
3. Serum Cr = 1ULN, endogenous creatinine clearance rate>60ml/min #Cockcroft Gault
formula#
- Women of childbearing age must undergo a pregnancy test #serum# within 7 days before
enrollment, and the result is negative. They are willing to use appropriate methods of
contraception during the trial period and 8 weeks after the last administration of the
trial drug; For males, surgical sterilization or agreement to use appropriate methods
of contraception during the trial period and 8 weeks after the last administration of
the trial drug should be considered; 9# Not participating in other clinical studies
before and during treatment; 10# The subjects voluntarily joined this study, signed an
informed consent form, had good compliance, and cooperated with follow-up.
Exclusion Criteria:
- If a subject meets any of the following conditions, they will not be allowed to enter
this study
- Patients with allergies or suspected allergies to research drugs or similar
drugs;
- Suffering from other malignant tumors within the past 5 years, excluding skin
basal cell or squamous cell carcinoma after radical surgery, or cervical
carcinoma in situ;
- Received live vaccine within 4 weeks prior to enrollment or possibly during the
study period;
- Suffering from active autoimmune diseases or having a history of autoimmune
diseases within 4 weeks prior to enrollment;
- Previously received allogeneic bone marrow transplantation or organ
transplantation;
- The patient currently has any disease or condition that affects drug absorption,
or the patient is unable to take medication orally;
- The patient currently has hypertension that cannot be controlled by medication,
which is defined as: patients with hypertension who cannot be well controlled
with a single antihypertensive drug treatment #systolic blood pressure = 150
mmHg, diastolic blood pressure = 100mmHg#; Or use two or more antihypertensive
drugs to control blood pressure in patients;
- Urinary routine indicates that urine protein is = 2+, and the 24-hour urine
protein volume is>1.0g;
- The patient currently has digestive tract diseases such as active gastric and
duodenal ulcers, ulcerative colitis, or active bleeding from unresectable tumors,
or other conditions determined by the researcher that may cause gastrointestinal
bleeding or perforation;
- Patients with significant evidence of bleeding tendency or medical history within
the 3 months prior to enrollment #bleeding>30 mL within 3 months, vomiting blood,
black stool, and rectal bleeding#, hemoptysis #fresh blood>5 mL within 4 weeks#,
or thromboembolic events #including stroke events and/or transient ischemic
attacks# within 12 months;
- Cardiovascular diseases with significant clinical significance, including but not
limited to acute myocardial infarction, severe/unstable angina, or coronary
artery bypass grafting surgery within 6 months prior to enrollment; Congestive
heart failure is classified by the New York Heart Association #NYHA# as>level 2;
Ventricular arrhythmia requiring medication treatment; Electrocardiogram #ECG#
shows a QT interval of = 480 milliseconds;
- Active or uncontrolled severe infection #= CTCAE level 2 infection#;
- Known human immunodeficiency virus #HIV# infection; Known clinically significant
history of liver disease, including viral hepatitis [known carriers of hepatitis
B virus #HBV# must exclude active HBV infection, i.e. HBV DNA positivity #>1 ×
104 copies/mL or>2000 IU/ml#; Known hepatitis C virus infection #HCV# and HCV RNA
positivity #>1 × 103 copies/mL, or other types of hepatitis or cirrhosis;
- According to the judgment of the researchers, patients deemed unsuitable for
inclusion in this study.
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