Key inclusion and exclusion criteria | |
---|---|
Inclusion criteria | Exclusion criteria |
Age between 18 and 80 years | Synchronous or metachronous (within 5 years) malignancies |
Unresectable locally advanced or metastatic pancreatic cancer that is pathologically diagnosed as adenocarcinoma | Females who are pregnant, or lactating |
No prior anti-tumor treatment for pancreatic cancer | New known or suspected uncontrolled metastases to brain |
ECOG PS: 0 to 2 | Serious or uncontrolled infectious disease (HIV、active tuberculosis、HBV DNA>103/ml) |
Life expectancy ≥3 months | Active autoimmune disease requiring systemic treatment in the past 2 years |
No history of autoimmune diseases | Immunodeficiency, or receipt of systemic steroid therapy or immunosuppressive therapy within 7 days of the first dose of the study drug |
Adequent organ function as below: | Tumor infiltration to any important blood vessels and nerves |
Absolute neutrophil count ≥1500/mm3 | Concurrent other kinds of chemotherapy, targeted therapy, hormone therapy, immunotherapy, radiotherapy (except local symptomatic radiotherapy) or traditional Chinese medicine during the trial course |
Platelet count ≥80,000/mm3 | History of chemotherapy or immune checkpoint inhibitors |
Haemoglobin ≥9.0 g/dL | Patients with serious complications, such as: |
Total bilirubin ≤2 × ULN | Uncontrollable cardiovascular disease, angina and arrhythmia |
Aspartate aminotransferase ≤3 × ULN (≤ 5 × ULN in patients with liver metastases) | History of myocardial infarction |
Alanine aminotransferase ≤3 × ULN (≤ 5 × ULN in patients with liver metastases) | History of hemorrage or thromboembolic events within the last 6 months |
Child-Pugh score ≤ 7 | Uncontrollable diabetes mellitus or hypertension |
Uric acid< 500 μmol/L | Uncontrolled intestinal lung disease or pulmonary fibrosis |
Serum creatinine ≤1.7 mg/dL | Other patients who are considered to be unsuitable for this study by the investigator |
Creatinine clearance ≥60 mL/min | |
Proteinuria ≤2 g/24 h | |
QTc interval ≤ 480 ms in ECG | |
Written informed consent |