Locally Advanced Pancreatic Cancer
Conditions
Interventions
Arm 2: Sequential combination therapy with camrelizumab:AG Sequential NAL-IRI, 5-FU/LV Combined with Camrelizumab
Arm 1: Sequential Therapy:AG sequential NAL-IRI, 5-FU/LV
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–80 years; gender; 2. Histologically confirmed (requiring needle biopsy) locally advanced pancreatic cancer; 3. No prior systemic treatment; 4. ECOG PS: 0–1; 5. Expected survival >= 12 weeks; 6. Normal function of major organs, meeting the following requirements (within 7 days prior to initiation of study treatment): (1) Complete blood count (CBC) must meet the following criteria: 1) Hemoglobin [HB] >= 90 g/L; 2) Absolute neutrophil count [ANC] >= 1.5 × 10?/L; 3) Platelet count [PLT] >= 80 × 10?/L; (2) Blood biochemistry tests must meet the following criteria: 1) Serum total bilirubin [TBIL] 50 mL/min (Cockcroft-Gault formula); (3) International Normalized Ratio [INR] = 2+, a 24-hour urine protein quantification may be performed; enrollment is permitted if the 24-hour urine protein quantification is < 1.0 g); 7. Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and must voluntarily use appropriate contraception during the observation period and for 8 weeks after the last administration of the study drug; for men, they must be surgically sterilized or agree to use appropriate contraception during the observation period and for 8 weeks after the last administration of the study drug; 8. Patients must be expected to demonstrate good compliance and be able to follow up on efficacy and adverse reactions as required by the protocol; 9. Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. History of other active malignant tumors within the past 1.5 years or concurrent active malignant tumors; 2. Uncontrolled clinical symptoms or diseases of the heart, such as: (1) Heart failure classified as Class II or higher according to the New York Heart Association (NYHA) criteria, or echocardiography showing an LVEF (left ventricular ejection fraction) 450 ms (males); QTc > 470 ms (females) (QTc interval calculated using the Fridericia formula; if QTc is abnormal, three consecutive measurements may be taken at approximately 2-minute intervals, and the average value used); 3. Patients with hypertension that cannot be controlled to normal ranges with antihypertensive medication (systolic blood pressure >=150 mmHg or diastolic blood pressure >=95 mmHg) (based on the average of blood pressure readings obtained from >=2 measurements); achieving these parameters through antihypertensive therapy is permitted; 4. Patients with coagulation abnormalities (INR > 1.5×ULN, APTT > 1.5×ULN) and a tendency to bleed; 5. Patients with active autoimmune disease or a history of autoimmune disease with a risk of recurrence; 6. Patients with a known history of severe allergy to the study drug; 7. Patients presenting with uncontrolled infection at screening; 8. Other patients deemed unsuitable for enrollment by the treating physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;progression-free survival; | — |
Countries
China
Contacts
Public ContactHao Chen
Lanzhou University Second Hospital
Outcome results
None listed