Gastric cance
Conditions
Interventions
Liposomal irinotecan + Fuquitinib + Sindillizumab:Liposomal irinotecan + Fuquitinib + 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 the study, voluntarily participate and sign an informed consent form (ICF) 2.The age range is 18-80 years old 3.The expected survival time is =3 months 4.Patients with histologically or pathologically confirmed unresectable or locally advanced gastric cancer and gastro-oesophageal junction adenocarcinoma 5.Patients who have previously received first-line therapy and whose disease has progressed after =6 months of disease control 6.According to RECIST1.1 criteria, the patient had at least one measurable target lesion 7.Eastern Cooperative Oncology Group(ECOG)Physical status score: 0-1 8.Absolute neutrophil count (ANC) =1.5×10^9/L, platelets =100×10^9/L, and hemoglobin =75 g/L 9.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 invasion); Total bilirubin =1.5 times the upper limit of normal (=3 times the upper limit of normal for patients with liver invasion) 10.Women of childbearing age must have had a pregnancy test (serological) negative within 7 days prior to enrollment and be willing to use an appropriate method of contraception during the trial
Exclusion criteria
Exclusion criteria: 1.Allergic reaction to any investigational drug or its ingredients 2.Patients who relapsed within 6 months after previous first-line immunosuppressive therapy 3.Human epidermal growth factor receptor 2 (HER-2) immunohistochemical IHC is known to be > 1+ 4.The investigational agent was a CYP3A4 strong inducer within 2 weeks prior to initial administration, or a CYP3A4 strong depressant or UGT1A1 strong depressant within 1 week 5.Uncontrolled systemic diseases (e.g. advanced infections, uncontrolled hypertension, diabetes, etc.) 6.Imaging confirmed intestinal obstruction 7.It has uncontrollable ascites, abdominal infection and pyloric obstruction 8.The volume of liver metastases exceeded 30% of the total liver volume 9.Patients with significant evidence or history of bleeding tendencies within 3 months (bleeding > 30 mL within 3 months, hematemesis, stool, and blood in the stool), hemoptysis (> 5 mL of fresh blood within 4 weeks), or thromboembolic events (including stroke events and/or transient ischemic attacks) within 12 months prior to enlistment 10.Hepatitis B, hepatitis C active infection (hepatitis B surface antigen positive and hepatitis B DNA more than 1x103 copies /mL; more than 1x103 copies /mL of HCV RNA) 11.Human immunodeficiency virus (HIV) infection (HIV antibody positive) 12.Previous or current co-occurrence of other malignancies (in addition to 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) 13.There is known to be symptomatic central nervous system metastasis and/or cancerous meningitis 14.The presence of medically uncontrolled hypertension before enrollment was defined as: systolic blood pressure =150 mmHg and/or diastolic blood pressure =100 mmHg 15.Urine routine indicated urine protein =2+, and 24-hour urine protein volume > 1.0g 16.Pregnant and lactating women and patients of childbearing age who do not want to use contraception 17.The investigators determined that patients were not suitable to participate 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;Quality of Life; | — |
Countries
China
Contacts
Public ContactShichao
Gaoxin Hospital of The First Affiliated Hospital of Nanchang University
Outcome results
None listed