| Eligibility |
Inclusion Criteria:
1. 18-75 years old, gender is not limited;
2. Histologically or cytologically proven metastatic or locally advanced gastric or
gastroesophageal junction adenocarcinoma
3. Programmed death-ligand 1 (PD-L1) positive subjects (CPS = 1), or those who have
achieved objective response to first-line Programmed death-1 (PD-1)/PD-L1 inhibitor
therapy, or previous first-line PD-1/PD-L1 inhibitor therapy Treatment of PFS = 6
months;
4. Prior chemotherapy, surgery, radiotherapy, or immunotherapy-related toxicity
(excluding alopecia) has resolved to CTCAE = grade 1;
5. Has measurable disease as determined by RECIST 1.1;
6. Subjects who can provide tissue samples (preferably freshly obtained tumor tissue
before second-line therapy) for central laboratory testing for PD-L1 expression level
determination;
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
8. Adequate organ function:
1. Blood routine (no blood transfusion within 14 days before treatment, no
granulocyte colony-stimulating factor, no correction with other drugs) i.
Neutrophil count (NE)>1.5*109/L; ii. Hemoglobin count (HGB) > 90 g/L; iii.
Platelet count (PLT)>100*109/L;
2. Coagulation function (no blood product transfusion within 14 days before
treatment) i. International Normalized Ratio (INR) or Prothrombin Time
(PT)=1.5*Upper Limit of Normal (ULN);
3. Blood biochemistry (liver and kidney function) i. Creatinine clearance =50
mL/min; ii. Total bilirubin (TBIL)=1.5×ULN; iii. Aspartate aminotransferase
(AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP)=2.5*ULN; iv.
Albumin > 2.7 g/dL
9. The urine protein of the patient is less than or equal to 1+;
10. According to the judgment of the investigator, the life expectancy is =6 months;
11. Able and willing to give written informed consent and has signed the informed consent
form (ICF), prior to performance of any trial activities.
12. Female patients must be surgically sterilized females, postmenopausal, or using some
form of highly effective contraception during treatment and within 12 weeks after
treatment; male patients must be surgically sterilized men, or during treatment and 6
months after treatment effective contraceptive method
Exclusion Criteria:
1. Human epidermal growth factor receptor 2 (HER2) positive;
2. History of treatment with multi-target small molecule inhibitors such as lenvatinib or
paclitaxel drugs;
3. Received systemic therapy (including chemotherapy, immunotherapy or targeted therapy)
or local therapy (including surgery, radiotherapy) for advanced disease within 14 days
before enrollment;
4. Hypertension that is difficult to control by drugs (systolic blood pressure = 160 mmHg
and diastolic blood pressure = 90 mmHg);
5. Patients with brain metastases, cancerous meningitis, spinal cord compression, or
diseases of the brain or leptomeninges found in imaging CT or MRI examinations during
screening;
6. Associated with refractory pleural effusion or ascites, such as pleural effusion or
ascites that requires puncture and drainage within 2 weeks before the first
administration;
7. Have other malignancies except cured cervical carcinoma in situ, non-melanoma skin
cancer, and superficial bladder tumors (Ta (non-invasive tumor), Tis (carcinoma in
situ), and T1 (tumor invading basement membrane));
8. Allergy to any study drug or excipients;
9. Chronic hepatitis B or HBV carriers with chronic hepatitis B virus (HBV) DNA exceeding
500 IU/mL, or patients with active hepatitis C virus (HCV) infection;
10. Presence of any active autoimmune disease or history of autoimmune disease (including
but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis,
hepatitis, hypophysitis, vasculitis, nephritis, thyroid function Hyperthyroidism,
hypothyroidism), or a known history of allogeneic organ transplantation or allogeneic
hematopoietic stem cell transplantation, or other investigators' assessment that they
have an impact on the study treatment;
11. Long-term heavy use of hormones or use of other immunomodulators;
12. Active infection;
13. Have been vaccinated with live or attenuated vaccines within 30 days before the first
dose, or plan to receive live or attenuated vaccines during the study period,
excluding the new crown vaccine;
14. Arterial/venous thrombotic events within 6 months, such as cerebrovascular accident,
deep vein thrombosis and pulmonary embolism;
15. Severe cardiovascular disease: myocardial ischemia or myocardial infarction above
grade II, or stent placement within 6 months before enrollment; poorly controlled
arrhythmia; according to the New York Heart Association (NYHA) criteria, III to IV
Grade 1 cardiac insufficiency, or echocardiography showed left ventricular ejection
fraction (LVEF) <50%;
16. History of interstitial lung disease or uncontrolled systemic disease, including
diabetes, acute lung disease, etc.;
17. Known human immunodeficiency virus (HIV) infection;
18. Any major surgery requiring general anesthesia has been performed within = 28 days
before the first dose;
19. There is an underlying medical condition or alcohol/drug abuse or dependence that is
not conducive to the administration of the study drug, or may affect the
interpretation of the results, or put the patient at a high risk of treatment
complications;
20. Participated in other therapeutic clinical studies.
|
