Surufatinib Combined With Gemcitabine Plus Nab-paclitaxel in Locally Advanced Pancreatic Cancer

Exclusion Criteria

• •1. Participants had a second primary malignancy detected prior to the first dose of study treatment, or has other malignancies diagnosed within 5 years prior to the first dose of study treatment, with the exception of radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ;
• •2. Allergy to study medication or excipients
• •3. With dysphagia or known malabsorption of drugs
• •4. Have participated in any other drug clinical trial and received the corresponding trial drug within the previous 4 weeks. Or are participating in other clinical studies that may interfere with this study.
• •5. Drug-uncontrolled hypertension；systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg; History of hypertensive crisis or hypertensive encephalopathy.
• •6. Patients with active gastric or duodenal ulcer, ulcerative colitis, intestinal obstruction, other gastrointestinal diseases, or active bleeding from unresectable tumors before enrollment, or other conditions that may cause gastrointestinal bleeding or perforation as judged by the investigator; Or have a history of bowel perforation or fistula and do not fully recover from surgery.
• •7. Patients had a history of arterial or deep-vein thrombosis within 6 months before enrollment ，or had evidence or history of bleeding tendency, regardless of severity, within 2 months before enrollment.
• •8. Stroke or transient ischemic attack occurred within 12 months before enrollment.
• •9. Incomplete healing of skin wounds, surgical sites, trauma sites, severe mucosal ulcers, or fractures.
• •10. Active bacterial, viral, or fungal infections requiring systemic treatment, defined as signs/symptoms associated with the infection that persist and do not improve despite appropriate antibiotic, antiviral, and/or other treatments
• •11. Known hepatitis B or C infection or a history of human immunodeficiency virus (HIV) infection ; Subjects receiving immunosuppressive or myelosuppressive drugs is considered to be associated with an increased risk of severe neutropenia complications by the investigators.
• •12. Severe cardiovascular disease, including unstable angina or myocardial infarction, occurred within 6 months before enrollment; Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months before enrollment; New York Heart Association (NYHA) classification of congestive heart failure \>Grade 2; Ventricular arrhythmias requiring medical therapy; LVEF(left ventricular ejection fraction)\<50%. Electrocardiogram (ECG) corrected QT interval ≥480 msec.
• •13. Clinically significant ascites
• •14. Clinically significant electrolyte disturbances.
• •15. Severe mental illness that may compromise the safety of the subjects or the integrity of the study data.
• •16. Any clinical or laboratory abnormalities or adherence that were deemed by the investigator to be inappropriate for participation in the trial.