Gastric Cancer
Conditions
Interventions
Intervention Group:First, oncolytic virus treatment was carried out as follows: intraperitoneal injection of oncolytic virus (day 1, 3, 5)
Chemotherapy Immunotherapy cycle: Tislelizumab (day 1): recommended dose is 200 mg every 3 weeks. The first infusion time should not be less than 60 minutes
Oxaliplatin 130 mg/m2 IV Q3W (day 1), the specific dose can be adjusted by the investigator according to the patients tolerance degree and the investigator's judgment), intravenous infusion on day 1,
A course of 3 weeks for a total of 6 courses (or the patient has tumor recurrence or metastasis (tumor recurrence or metastasis needs to be determined by imaging)
Oral capecitabine 1000 mg/m2 twice daily (days1-14) Q3W (XELOX)
Sponsors
Renji Hospital ,Shanghai Jiaotong University School Of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily join this study and sign the informed consent form; 2. >=18 years old, 6 months; 8. Negative adenovirus pre-existing antibodies, such as anti-recombinant human adenovirus type 5 virus antibodies (including IgG and IgM), anti-adenovirus antibodies (such as Anti-Ad5), anti-drug antibodies (ADA); 9. Adequate organ function, subjects must meet the following laboratory indicators: (1) Absolute neutrophil value (ANC) >=1.5x10^9L; (2) In the case of no blood transfusion in the past 14 days, platelet >=100×10^9/L; (3) Hemoglobin >8g/dL; (4) Total bilirubin =60 ml/min; (7) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <=1.5 times ULN; (8) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; 10. For female subjects of childbearing age, a urine or serum pregnancy test should be negative within 3 days prior to receiving the first dose of study drug (Cycle 1 Day 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is ordered. Women of non-childbearing age are defined as at least 1 year postmenopausal, or have undergone surgical sterilization or hysterectomy; 11. If there is a risk of conception, all subjects (male or female) must use contraception with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy).
Exclusion criteria
Exclusion criteria: 1. Subjects withdraw informed consent and request withdrawal; 2. Patients with strong positive HER2 expression and ERBB2 gene amplification were excluded; 3. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 4. Untreated active hepatitis B (defined as HBsAg positive and simultaneous detection of HBV-DNA copy number greater than the upper limit of normal in the laboratory department of the study center); Hepatitis B subjects who meet the following criteria can also be enrolled: 1) HBV viral load <1000 copies/ml (200 IU/ml) before the first dose, subjects should receive anti-HBV therapy throughout the study chemotherapy drug treatment period to avoid viral reactivation 2) For subjects with anti-HBc ( ), HBsAg ( -), anti HBs ( -) and HBV viral load ( -) do not need to receive prophylactic anti-HBV therapy, but close monitoring of viral reactivation is required; 5. Subjects with active HCV infection (positive HCV antibody and HCV-RNA level higher than the lower limit of detection); 6. Active autoimmune disease requiring systemic treatment (e.g., use of disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency, etc.) is not considered systemic therapy; 7. Uncontrolled active infection; 8. Poor compliance of subjects; 9. Subjects lost to follow-up or pregnant, lactating, or pregnant; 10. Other circumstances that the investigator considers necessary to withdraw from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of safety and treatment-related adverse events;1-year overall survival;Peritoneal Cancer Index (PCI) score for abdominal tumor burden; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year progression-free survival;3-year progression-free survival;3-year overall survival; | — |
Countries
China
Contacts
Public ContactZhang Zizhen
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed