| Eligibility |
Inclusion Criteria:
1. Age: 18 years old, male or female;
2. According to the NCCN clinical practice guidelines (2023.V2 version),
multidisciplinary and imaging evaluation for patients with resectable pancreatic
cancer, resectable defined as: by imaging examination, the criteria of radical
resection of tumor is no distant metastasis, the artery (trunk celiac, superior
mesenteric artery or common hepatic artery), and the tumor did not invade the superior
mesenteric vein and portal vein, or invasion but not more than 180 and the venous
contour is normal.
3. Have not received any anti-tumor therapy (including radiotherapy, ablation,
chemotherapy, targeted therapy, immunotherapy, etc.) or research drug therapy; 4. At
least one measurable lesion must be used as the target lesion (according to the RECIST
v1.1 criteria);
5. ECOG:0~1; 6. Expected survival period of 3 months; 7. Main organ function, meeting the
following criteria (without receiving any blood components, cell growth factors within the
14 days prior to randomization):
1. Neutrophils 1.5 * 109 / L; platelets 80 * 109 / L; 9 g/dl hemoglobin and 3 g/dl serum
albumin;
2. The upper limit of total bilirubin is 1.5 times (biliary obstruction allows biliary
drainage); the upper limit of ALT and AST is 3 times (for patients of liver
metastasis, it can be relaxed to 5 times the upper limit of normal);
3. The upper limit of normal serum creatinine is 1.5 times, and the creatinine clearance
is 60ml / min;
4. The upper limit of INR is 1.5 times and the upper limit of APTT is 1.5 times (for
stable doses of anticoagulant therapy such as low molecular weight heparin or warfarin
and INR can be screened within the expected treatment range of anticoagulant);
5. ECG: QTcF 450ms (male), 470ms (female);
6. Cardiac color ultrasound: LVEF (left ventricular ejection fraction) 50%; 8. Women of
childbearing age must have a negative blood pregnancy test within 3 days before
randomization and be willing to use appropriate contraception during the trial and
within 6 months of treatment. For men, it should be surgical sterilization, or consent
to use appropriate methods of contraception during the study period and within 3
months after the end of treatment; 9. Subjects volunteered to join the study and
signed the informed consent form.
Exclusion Criteria:
1. Patients with pancreatic cancer arising from non-pancreatic ductal epithelium,
including pancreatic neuroendocrine carcinoma, pancreatic acinar cell carcinoma,
pancreatic pancreoblastoma, and solid-pseudopapillary tumors;
2. Patients with known central nervous system metastases;
3. Severe gastrointestinal dysfunction (bleeding, obstruction; inflammation greater than
grade 2; diarrhea greater than grade 1);
4. Within 2 weeks before randomization, the third space effusion (such as a large amount
of pleural fluid) (no intervention after removing the drainage tube);
5. Patients with clinical symptoms of ascites, requiring puncture, drainage, who have
received ascites drainage within the previous 3 months (only a small amount of ascites
on imaging and controllable, except those without clinical symptoms);
6. Current subjects with interstitial pneumonia or interstitial lung disease, or a
history requiring hormonal therapy, or other pulmonary fibrosis, mechanical pneumonia
(e. g., bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic
pneumonia, idiopathic pneumonia or active CT during screening that may interfere with
the judgment and management of immune-related pulmonary toxicity; active tuberculosis;
7. Patients with active autoimmune disease or a history of autoimmune disease that may
relapse [including but not limited to autoimmune hepatitis, interstitial pneumonia,
uveitis, optis, enteritis, vasculitis, nephritis, hyperthyroidism, reduced thyroid
function (only controlled by hormone replacement therapy can be enrolled)]; skin
diseases without systemic treatment, such as vitiligo, psoriasis, alopecia, controlled
type I diabetes or asthma in childhood has been completely alleviated in adults
without any intervention;
8. Known peripheral neuropathy (CTCAE Grade 3);
9. Known dihydropyrimidine dehydrogenase (low activity) or deficiency;
10. Severe infection (CTCAE> 2), such as severe pneumonia, bacteremia, infectious
complications, requiring hospitalization, occurred within 4 weeks of randomization;
symptoms and signs of infection within 2 weeks of randomization (except in cases of
prophylactic antibiotics);
11. Received any of the following treatments:
(1)Concomitant medication containing CYP3A4, CYP2C8 strong inhibitor / strong inducer or
strong UGT1A1 inhibitor within 2 weeks before randomization; (2)Immunosuppressants or
systemic hormone therapy within 2 weeks prior to randomization to achieve immunosuppressive
purposes (dose> 10mg prednisone / day or other efficacy hormones); (3)Received radiation
therapy within 2 weeks before randomization; (4)Receiving major surgery (such as
thoracotomy, laparotomy, etc.) within 4 weeks before randomization; (5)Have received any
other clinical study drug treatment within 4 weeks before randomization, except for an
observational (non-interventional) clinical study or interventional clinical study
follow-up.
12. Abnormal coagulation, bleeding tendency or undergoing thrombolytic or anticoagulant
therapy. Prophylactic use of low-dose aspirin (100mg / day), low molecular weight heparin
(enoxaparin 40mg / day and other low molecular weight heparin at its equivalent doses) is
allowed; 13. cardiac clinical symptoms or diseases that are not well controlled, such as:
(1) heart failure; (2) unstable angina; (3) myocardial infarction within 6 months; (4)
patients with clinically significant supraventricular or ventricular arrhythmias who need
treatment or intervention; 14. Malignant tumors other than pancreatic cancer within 5 years
before randomization, except for adequately treated cervical carcinoma in situ, skin basal
cell, or squamous epithelial cell carcinoma; 15. Those known to be allergic to PD-L1,
irinotecan liposomal, other liposomal products, oxaliplatin, 5-FU, leucovorin and any of
the components of the above products; 16. Those known to have acquired immune deficiency
syndrome (AIDS) or HIV test positive, active syphilis; 17. A clear past history of
neurological or psychiatric disorders, including epilepsy or dementia; 18. By the judgment
of the investigator, the subject has other factors that may be forced to terminate the
study, such as non-compliance protocol, with other serious diseases (including mental
illness) need to combine treatment, clinical significant laboratory value seriously
abnormal, family or social factors, may affect the safety or trial data collection of
subjects.
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