| Eligibility |
Inclusion Criteria:
1. Age 18-75 years old, male or female; 2. Histologically or cytologically confirmed
diagnosis of pancreatic cancer (originating from the pancreatic ductal epithelium), with
clinical records showing metastatic pancreatic cancer (stage IV according to the AJCC 8th
edition TNM staging of pancreatic cancer); 3. Have not received any anti-tumor therapy
(including chemotherapy, targeted, immunotherapy, etc.); 4. Must have at least one
measurable lesion as a target lesion (according to RECIST v1.1 criteria); the target lesion
should not have received localized treatment such as radiotherapy (lesions located within
the area of previous radiotherapy may also be selected as target lesions if progression is
confirmed to have occurred and meets RECIST1.1 criteria); 5. ECOG: 0 to 1; 6. Expected
survival = 3 months; 7. Good major organ function, i.e., the following criteria are met (in
the absence of receiving any blood components, cell growth factors within 14 days prior to
randomization):
1. Neutrophils =1.5*109/L; platelets =80*109/L; hemoglobin =9g/dl; serum albumin =3g/dl;
2. Total bilirubin = 1.5 times the upper limit of normal value (biliary obstruction
allows biliary drainage); ALT and AST = 3 times the upper limit of normal value (for
patients with hepatic metastases, it can be relaxed to = 5 times the upper limit of
normal value);
3. Serum creatinine =1.5 times the upper limit of normal value, creatinine clearance
=50ml/min;
4. INR =1.5 times the upper limit of normal value and APTT =1.5 times the upper limit of
normal value (for the use of a stable dose of anticoagulation therapy, such as low
molecular heparin or warfarin, and the INR is within the expected therapeutic range of
anticoagulants can be screened);
5. Electrocardiogram: QTcF =450ms (men), =470ms (women);
6. Cardiac ultrasound: LVEF (left ventricular ejection fraction) =50%; 8. Women of
childbearing potential must have had a negative blood pregnancy test within 3 days
prior to randomization and be willing to use an appropriate method of contraception
during the trial and for 6 months after completion of treatment. For men, this should
be surgical sterilization or agreement to use an appropriate method of contraception
for the duration of the study and for 3 months after completion of treatment; 9.
Subjects voluntarily enroll in this study by signing an informed consent form.
Exclusion Criteria:
1. patients with pancreatic cancer originating from non-pancreatic ductal epithelium,
including pancreatic neuroendocrine carcinoma, pancreatic follicular cell carcinoma,
pancreatoblastoma, and solid-pseudopapillary tumors;
2. patients with known central nervous system metastases;
3. severe gastrointestinal dysfunction (with bleeding, obstruction; inflammation greater
than grade 2; diarrhea greater than grade 1);
4. the presence of third interstitial fluid (e.g., massive pleural fluid) that could not
be stabilized (without interventional therapy after drain removal) except for ascites
within 2 weeks before randomization;
5. Patients with clinically symptomatic ascites who require puncture or drainage or who
have received ascites drainage within the previous 3 months (except for imaging that
shows only a small amount of ascites that is manageable but not accompanied by
clinical symptoms);
6. current concomitant interstitial pneumonia or interstitial lung disease, or a prior
history of interstitial pneumonia or interstitial lung disease requiring hormonal
therapy, or other pulmonary fibrosis that may interfere with the determination and
management of immune-related pulmonary toxicity, mechanized pneumonia (e.g., occlusive
bronchiectasis), pneumoconiosis, drug-associated pneumonitis, idiopathic pneumonitis,
or active pneumonia or severely impaired pulmonary function as demonstrated by chest
CT at the Screening Period Subjects; active tuberculosis;
7. the presence of active autoimmune disease or a history of autoimmune disease with
potential for relapse [including, but not limited to, autoimmune hepatitis,
interstitial pneumonitis, uveitis, enteritis, pituitary gland inflammation,
vasculitis, nephritis, hyperthyroidism, and hypothyroidism (subjects who can be
controlled by hormone replacement therapy only are eligible for enrollment)]; subjects
who have a skin disease that does not require systemic treatment such as vitiligo,
psoriasis, alopecia that Controlled type I diabetes mellitus receiving insulin therapy
or asthma that has completely resolved in childhood and does not require any
intervention in adulthood may be enrolled;
8. known peripheral neuropathy (CTCAE = grade 3);
9. a serious infection (CTCAE > grade 2) within 4 weeks prior to randomization, such as
severe pneumonia, bacteremia, or complications of infection requiring hospitalization;
signs and symptoms of infection requiring intravenous antibiotic therapy (except for
prophylactic use of antibiotics) within 2 weeks prior to randomization;
10. received any of the following treatments: 1) Immunosuppressive or systemic hormone
therapy for immunosuppression within 2 weeks prior to randomization (dose >10 mg/day
prednisone or other equipotent hormone); 2) Radiation therapy within 2 weeks prior to
randomization; 3) Major surgery (e.g., open thoracic surgery, open abdominal surgery,
etc.) within 4 weeks prior to randomization; 4) Received any other clinical study
medication within 4 weeks prior to randomization, unless it was an observational
(non-interventional) clinical study or an interventional clinical study follow-up.
11. abnormal coagulation, bleeding tendency or undergoing thrombolytic or anticoagulant
therapy. Prophylactic use of low-dose aspirin (=100mg/day), low molecular heparin
(enoxaparin 40mg/day and other low molecular heparin at its equivalent dose) is
allowed;
12. patients with cardiac clinical conditions or diseases that are not well controlled,
such as (1) NYHA class 2 or higher heart failure, (2) unstable angina pectoris, (3)
myocardial infarction within 6 months, and (4) clinically significant supraventricular
or ventricular arrhythmias that require treatment or intervention;
13. malignancy other than pancreatic cancer within 5 years prior to randomization, with
the exception of adequately treated carcinoma in situ of the cervix, basal cell or
squamous epithelial cell carcinoma of the skin;
14. known hypersensitivity to PD-L1, albumin paclitaxel, gemcitabine, decitabine, and any
of the components of the above products;
15. known to have acquired immunodeficiency syndrome (AIDS) or HIV test positive, active
syphilis infection;
16. previous history of definite neurological or psychiatric disorders, including epilepsy
or dementia;
17. Subjects who, in the judgment of the investigator, have other factors that may cause
them to be forced to terminate the study midway, such as non-compliance with the
protocol, other serious illnesses (including psychiatric illnesses) that require
comorbid treatment, grossly abnormal values of clinically significant laboratory
tests, familial or social factors that may affect the safety of the subject or the
collection of trial data.
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