Pancreatic cancer
Conditions
Interventions
Experimental group:Liposomal irinotecan: 60 mg/m^2, IV, d1 intravenous infusion for 90 minutes
Oxaliplatin: 85mg/m^2, IV, d1, intravenous infusion for 2 hours
Fluorouracil: 2400mg/m^2, IV, d1, intrave
Sponsors
Shanghai Fudan University HuaShan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily join this study and sign the informed consent form; 2. Age: 18-75 years old (including both ends), male or female; 3. Histologically confirmed borderline resectable pancreatic cancer: defined as (1) tumor contact with the portal vein-superior mesenteric vein > 180°, or contact =12 weeks; 8. Normal function of major organs, meeting the following requirements (within 7 days prior to starting study treatment): (1) Routine blood examination: (no blood transfusion, no use of granulocyte colony-stimulating factor [G-CSF], no correction with medication within 14 days before screening): 1) Hemoglobin [HB]>=90g/L; 2) Absolute neutrophil count [ANC] >=1.5×10^9/L; 3) Platelets [PLT]>=80×10^9/L; (2) Blood biochemical tests must meet the following criteria (no albumin transfusion in the 14 days before screening): 1) Serum total bilirubin [TBIL] 50ml/min (Cockcroft-Gault formula); (3) International normalized ratio [INR] =2, 24-hour urine protein quantification can be performed, and 24-hour urine protein quantification <1.0g can be enrolled); 9. Women of childbearing potential must have a negative pregnancy test (serum or urine) result within 7 days prior to enrollment and voluntarily use an appropriate method of contraception during the observation period and within 8 weeks after the last administration of study drug; For males, should be surgically sterile, or agree to use an appropriate method of contraception during the observation period and for 8 weeks after the last administration of study drug; 10. Those who are expected to have good compliance can follow up the efficacy and adverse reactions according to the requirements of the protocol.
Exclusion criteria
Exclusion criteria: 1. Have other active malignant tumors within 5 years or concurrently; 2. Uncontrolled cardiac clinical symptoms or disease, such as: (1) Class II or higher cardiac insufficiency according to the New York Heart Association (NYHA) criteria or cardiac ultrasound: LVEF (Left Ventricular Ejection Fraction) 450ms (men); QTc>470ms (women) (QTc interval is calculated using the Fridericia formula; if the QTc is abnormal, three consecutive measurements can be taken at approximately 2-minute intervals and averaged); 3. Hypertension (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg) that cannot be reduced to the normal range with antihypertensive medication (based on the average of >=2 BP readings) is permitted to be achieved with antihypertensive therapy; 4. coagulation abnormalities (INR > 1.5 x ULN, APTT > 1.5 x ULN) in those with bleeding tendencies; 5. presence of active autoimmune disease or history of autoimmune disease with potential for relapse; 6. severe diarrhea; 7. known history of severe allergy to the study drug; 8. uncontrolled infection at screening; 9. other patients who, in the opinion of the treating physician, are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-Free Survival;Progression-Free Survival;Overall Survival ;Lymph node metastasis rate;CA199 reaction rate;Safety; | — |
Countries
China
Contacts
Public ContactFu Deliang
Shanghai Fudan University HuaShan Hospital
Outcome results
None listed