advanced gastric cancer
Conditions
Interventions
A:liposomal irinotecan combined with fluorouracil
Sponsors
The affiliated hospital of Qingdao university
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: (1) Be able to understand the research process, volunteer to participate in the study, and sign an informed consent form. ; (2) Over 18 years old; (3) Histologically or cytologically confirmed unresectable locally advanced, recurrent or metastatic adenocarcinoma of gastric cancer; (4) At least one evaluable target lesion according to the solid tumor evaluation criteria (RECIST) version 1.1; (5) Failure of at least first-line standard therapy; (6) ECOG 0~2; (7) Expected survival time = 3 months; (8) Adequate organ function: neutrophil count = 1.5 × 10*9/ L; platelet count = 90 ×10*9/ L; hemoglobin = 90 g / L; Total bilirubin < the upper limit of normal value;AST and ALT = 2.5 times the upper limit of normal value; serum creatinine = 1.2mg/dL and creatinine clearance =50mL/min; (9) No pregnant or nursing female patients. Women or men of childbearing age should use effective contraception during the study and for 6 months after the end of study treatment.
Exclusion criteria
Exclusion criteria: (1) History of other malignacis in the past 5 years (except for cured cervical carcinoma in situ or basal cell carcinoma of the skin); (2) Active central nervous system metastasis; (3) Pulmonary fibrosis or interstitial pneumonia was diagnosed within 28 days before enrollment; (4) Active hepatitis B, hepatitis C and HIV infection; (5) According to the investigator's judgment, patients with a clear tendency of gastrointestinal bleeding;(6) Within 6 months before informed consent, patients with a history of gastrointestinal perforation and/or fistula, and patients with gastric cancer perforation who have undergone surgical resection of the primary lesion of gastric cancer; (7) Wthin 3 months before informed consent, history of intestinal obstruction or inflammatory bowel disease or extensive bowel resection, Crohn's disease and ulcerative enteritis;(8) major cardiovascular disease, including any of the following: a) Within 6 months before enrollment, congestive heart failure (defined as New York Heart Association grade III or IV), myocardial infarction, unstable angina, coronary angioplasty, stenting, coronary artery bypass grafting, cerebrovascular accident, or hypertensive crisis; b) A history of clinically significant ventricular arrhythmias; c) Friderica-modified QT interval >450 msec in men and >470 msec in women;d) History of congenital long QT syndrome or family history; e) Arrhythmias requiring antiarrhythmic drug therapy; f) History of deep vein thrombosis, pulmonary embolism, or any other major thromboembolism within 3 months before enrollment;(9) Severe prolonged diarrhoea; (10) Use of strong inhibitors or inducers such as CYP3A4, CYP2C8 and UGT1A1; (11) Severe mental illness; (12) Pleural effusion or abdominal effusion with clinical symptoms; (13) Patients who have previously participated in other clinical trials but have not discontinued the trial; (14) The investigator assessed patients who were not suitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate,ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate,DCR;progression-free survival, PFS ;Overall Survival, OS; | — |
Countries
China
Contacts
Public ContactZimin Liu
The affiliated hospital of Qingdao university
Outcome results
None listed