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Table 1 The key eligible criteria of this trial

From: Study protocol for an open-label, single-arm, phase Ib/II study of combination of toripalimab, nab-paclitaxel, and gemcitabine as the first-line treatment for patients with unresectable pancreatic ductal adenocarcinoma

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  
  1. Abbreviations: ULN Upper Limit Of Normal, ECOG PS Eastern Cooperative Oncology Group performance status, ECG Electrocardiograph
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