gastric cancer
Conditions
Interventions
experimental group:Irinotecan liposome combined with Sindillizumab
Sponsors
Hubei Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients fully understand the study, voluntarily participate and sign an informed consent form (ICF); 2. Ages 18-75; 3. Expected survival time >=3 months; 4. Patients with unresectable locally advanced, recurrent, or metastatic gastric adenocarcinoma confirmed by histology or pathology; 5. Patients who have failed first-line standard treatment; 6. PD-L1 expression level detected CPS>=5; 7. According to RECIST1.1 criteria, the patient has at least one target lesion with measurable diameter (tumor lesion with CT scan diameter >=10mm, lymph node lesion with CT scan diameter >=15mm, scanning layer thickness 5mm); 8. ECOG score 0-1; 9. Vital organ function meets the following requirements: Use of any blood component, cell growth factor, G-CSF, or other hematopoietic stimulants is not permitted during the first 14 days of enrollment. Bone marrow function: neutrophils >=1.5×109/L, platelets >=90×109/L, hemoglobin >=90g/L; Liver and kidney function: serum creatinine <=1.5 times the upper limit of normal value; AST and ALT <=2.5 times the upper limit of normal (<=5 times the upper limit of normal for patients with liver metastasis); Total bilirubin <=1.5 times the upper limit of normal (<=3 times the upper limit of normal for patients with liver metastasis); 10. Women of childbearing age must take a pregnancy test (serological test) within 7 days prior to enrollment, with a negative result, and be willing to use appropriate methods of contraception during the test period; 11. Consent to provide blood and histological samples.
Exclusion criteria
Exclusion criteria: 1. Allergic reaction to any investigational drug or its ingredients; 2. Investigational drugs: CYP3A4 strong inducer has been used within 2 weeks before the first administration, or CYP3A4 strong depressant or UGT1A1 strong depressant has been used within 1 week; 3. Uncontrolled systemic diseases (such as active infections, uncontrolled hypertension, diabetes, rheumatic immune diseases, etc.);; 4. Severe cardiovascular disease in the 6 months prior to enrollment, including but not limited to: stable angina pectoris with functional classification III to IV; Unstable angina pectoris or myocardial infarction death; NYHA Grade III-IV congestive heart failure; Severe arrhythmias requiring medical treatment (if ventricular rate can be controlled, subjects with asymptomatic atrial fibrillation are allowed to be included); Severe arterial/venous thrombosis events (e.g. cerebral hemorrhage, cerebral infarction, deep vein thrombosis, pulmonary embolism, arterial thromboembolism, etc.); 5. Received immunosuppressive therapy (e.g. Cyclosporine) within 14 days prior to enrollment or required daily systemic steroid therapy (e.g. >20 mg/ day prednisone or equivalent); 6. Radiographically confirmed history of intestinal obstruction or of inflammatory bowel disease or extensive enterectomy (partial resection of the colon or extensive resection of the small intestine with chronic diarrhea), Crohn's disease, ulcerative colitis; 7. Uncontrollable ascites, abdominal infection, pyloric obstruction; 8. Hepatitis B, hepatitis C active infection (hepatitis B surface antigen positive and hepatitis B DNA more than 1x10^3 copies /mL or 2000IU/mL; HCV RNA more than 1x10^3 copies /mL or 2000IU/mL); 9. Human immunodeficiency Virus (HIV) infection (HIV antibody positive); 10. Previous or current co-occurrence of other malignancies (other than non-melanoma basal cell carcinoma of the skin that is effectively controlled, breast/cervical carcinoma in situ, and other malignancies that have been effectively controlled without treatment within the past five years); 11. Patients who have previously used irinotecan chemotherapy; 12. Immune-related adverse events with NCI-CTCAE 5.0 grade score >=3 during previous immunotherapy (such as cardiotoxicity, hypothyroidism, adrenal insufficiency, etc.); 13. Pregnant and lactating women and patients of childbearing age who do not want to use contraception; 14. Circumstances in which other investigators have determined that participation in this study is not appropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate, ORR;Overall Survival, OS;Incidence and severity of hematologic and non-hematologic adverse events; | — |
Countries
China
Contacts
Public ContactXingjun Liang
Hubei Cancer Hospital (HBCH)
Outcome results
None listed