A Phase Ib/II Clinical Study of Regorafenib Combined With Toripalimab and Albumin-bound Paclitaxel for the Third-line Treatment of Advanced Pancreatic Cancer

Exclusion Criteria

• •1. Have hypersensitivity reactions to any research drug or its components;
• •2. Concurrent serious uncontrolled infections or other serious uncontrolled accompanying diseases, moderate or severe kidney injury; (such as progressive infection, uncontrollable hypertension, diabetes, etc.);
• •3. Heart function and disease meet one of the following conditions:
• •1. Long QTc syndrome or QTc interval\>480 ms;
• •2. Complete left bundle branch block, grade II or III atrioventricular block;
• •3. Severe and uncontrolled arrhythmias requiring medication treatment;
• •4. New York College of Cardiology classification ≥ III;
• •5. Heart ejection fraction (LVEF) below 50%;
• •6. History of myocardial infarction, unstable angina, and severe unstable ventricular arrhythmia within 6 months prior to recruitment or any other arrhythmia requiring treatment, history of clinically severe pericardial disease, or there may be electrocardiographic evidence of acute ischemic or active conduction system abnormalities.
• •4. Active infection of hepatitis B and C (hepatitis B virus surface antigen is positive and hepatitis B virus DNA exceeds 1x103 copies/mL; Hepatitis C virus RNA exceeding 1x103 copies/mL).Asymptomatic chronic carriers of hepatitis B or hepatitis C excluded;
• •5. Human immunodeficiency virus (HIV) infection (HIV antibody positive);
• •6. Imaging confirms intestinal obstruction;
• •7. Previously or currently suffering from other malignant tumors simultaneously (Except for non melanoma basal cell carcinoma and breast/cervical carcinoma in situ that have been effectively controlled and other malignant tumors that have been effectively controlled without treatment in the past five years);
• •8. Pregnant and lactating women, as well as reproductive age patients who are unwilling to take contraceptive measures;
• •9. Patients who require treatment for merging with other malignant tumors;
• •10. History of pulmonary hemorrhage/hemoptysis ≥ grade 2 (defined as at least 2.5mL of bright red blood) within one month prior to the first administration;
• •11. Within 6 months prior to the first administration, there are arterial embolism, severe bleeding (excluding bleeding caused by surgery), and a tendency for severe bleeding;
• •12. Merge symptomatic brain metastases, meningeal metastases, spinal cord tumor invasion, and spinal cord compression syndrome;
• •13. Have used other clinical trial drugs within one month before the first administration;
• •14. The researchers have determined that patients who are not suitable to participate in this study.