Gastric cance
Conditions
Interventions
Liposomal irinotecan + IL-2 + Sindillizumab:Liposomal irinotecan + IL-2 + Sindillizumab
Sponsors
Gaoxin Hospital of The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients fully understand this study, voluntarily participate and sign the informed consent form (ICF); 2. Age 18-80 years old; 3. Expected survival time>= 3 months; 4. Patients with unresectable or locally advanced gastric cancer and adenocarcinoma of the gastroesophageal junction confirmed by histology or pathology; 5. Progression after prior first-line therapy or adjuvant therapy within 6 months; 6. According to the criteria in RECIST1.1, the patient has at least one target lesion with measurable diameter (the long diameter of the CT scan of the tumor lesion is >= 10mm, the short diameter of the CT scan of the lymph node lesion is >=15mm, and the thickness of the scan layer is 5mm); 7. ECOG score 0-1 points; 8. Bone marrow function: neutrophil >= 1.5×10^9/L, platelet >= 100×10^9/L, hemoglobin >=75g/L; 9. Liver and kidney function: serum creatinine <= 1.5 times the upper limit of normal, AST and ALT <= 2.5 times the upper limit of normal (for patients with liver invasion <= 5 times the upper limit of normal), total bilirubin <= 1.5 times the upper limit of normal (for patients with liver invasion<= 3 times the upper limit of normal); 10. Women of childbearing potential must have a pregnancy test (serum) within 7 days prior to enrollment with a negative result, and are willing to use appropriate methods of contraception during the trial; 11. Consent to provide histological samples
Exclusion criteria
Exclusion criteria: 1. Allergic reaction to any of the study drugs or their components; 2. Known human epidermal growth factor receptor 2 (HER-2) immunohistochemistry IHC >1; 3. Use of strong inducers of CYP3A4 within 2 weeks before the first dose of the experimental drug, or use of strong inhibitors of CYP3A4 or strong inhibitors of UGT1A1 within 1 week; 4. Uncontrollable systemic diseases (such as advanced infection, uncontrollable hypertension, diabetes, etc.); 5. Confirmed diagnosis of intestinal obstruction by imaging or history of the following diseases: inflammatory bowel disease or extensive bowel resection (partial colectomy or extensive small bowel resection, complicated by chronic diarrhea), Crohn's disease, ulcerative colitis; 6. Uncontrollable ascites, abdominal infection, pyloric obstruction; 7. The volume of liver metastases exceeds 30% of the total volume of the liver; 8. Patients with obvious evidence or history of bleeding tendency within 3 months before enrollment (bleeding > 30 mL within 3 months, hematemesis, black stool, hematochezia), hemoptysis (> 5 mL of fresh blood within 4 weeks) or thromboembolic events (including stroke events and/or transient ischemic attack) within 12 months; 9. Active hepatitis B and hepatitis C infection (hepatitis B virus surface antigen positive and hepatitis B virus DNA more than 1x10^3 copies/mL; hepatitis C virus RNA more than 1x10^3 copies/mL); 10. Human immunodeficiency virus (HIV) infection (HIV antibody positive); 11. Previous or present concomitant other malignancies (except for basal cell carcinoma of the skin that has been effectively controlled by non-melanoma, carcinoma in situ of the breast/cervix, and other malignancies that have been effectively controlled without treatment in the past five years); 12. Known presence of symptomatic central nervous system metastases and/or carcinomatous meningitis; 13. Presence of hypertension uncontrolled by medication prior to enrollment, prescribed: systolic blood pressure >= 150 mmHg and/or diastolic blood pressure >= 100 mmHg; 14. Those whose urine routine showed that urine protein was >=2 and the amount of urine protein in 24 hours was > 1.0g; 15. Pregnant and lactating females and patients of childbearing age who are unwilling to take contraceptive measures; 16. Other conditions judged by the investigator to be unsuitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Duration of Overall Response;Progression Free Survival;Overall Survival;Safety;Quality of Life; | — |
Countries
China
Contacts
Public ContactShichao
Gaoxin Hospital of The First Affiliated Hospital of Nanchang University
Outcome results
None listed