A Prospective, Single-arm, Exploratory Clinical Study of Sintilimab Injection in Combination With Paclitaxel (Albumin-bound) and Gemcitabine in Translational Therapy in Patients With Unresectable Locally Advanced Pancreatic Cancer.

Who cannot join

• 1. Malignant diseases other than pancreatic cancer were diagnosed within 5 years prior to first administration (excluding radical basal cell carcinoma of the skin, squamous carcinoma of the skin, and/or radical resected carcinoma in situ); 2. Patients who are currently participating in an interventional clinical study or have been treated with another study drug or study device within 4 weeks prior to initial administration; 3. Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target another stimulating or co-inhibiting T-cell receptor (e.g., CTLA-4, OX-40, CD137); 4. Received systemic therapy with anti-tumor indications of Proprietary Chinese medicines or immunomodulatory drugs (including interferon and interleukin, except local use for ascites control) within 2 weeks before the first administration; 5. An active autoimmune disease requiring systemic therapy (e.g., palliative drugs, glucocorticoids or immunosuppressants) has occurred within 2 years prior to first dosing. Alternative therapies (e.g. thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary dysfunction) are not considered systemic; 6. Patients who were receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation, or other topical glucocorticoid) or any other form of immunosuppressive therapy within 7 days prior to initial dosing; Note: Physiological doses of glucocorticoids (≤10 mg/ day of prednisone or equivalent) are permitted; 7. Allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation is known; 8. Those who are known to be allergic to active ingredients or excipients of sintilimab, gemcitabine and albumin-paclitaxel; 9. Has not fully recovered from toxicity and/or complications associated with any intervention prior to initiation of treatment (i.e., ≤ grade 1 or baseline, excluding fatigue or hair loss); 10. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); 11. Uncontrolled active hepatitis B (defined as HBsAg positive with hbV-DNA copy number greater than the upper limit of the normal value in the laboratory department of the research center);
• Note: Hepatitis B subjects who meet the following criteria can also be enrolled:
• HBV viral load <1000 copies/mL (200 IU/ml) before initial administration, subjects should receive anti-HBV therapy throughout study drug therapy to avoid virus reactivation
• For subjects resistant to HBc (+), HBsAg (-), anti-HBS (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring of virus reactivation is required 12. Active HCV-infected subjects (HCV antibody positive and HCV-RNA level above the detection limit); 13. Received live vaccine within 30 days prior to initial administration (cycle 1, day 1); Note: Acceptance of injectable inactivated virus vaccine against seasonal influenza is permitted within 30 days prior to first administration; Intranasally administered live attenuated flu vaccines are not allowed.
• 14. Pregnant or lactating women; 15. Presence of any serious or uncontrollable systemic illness, such as:
• Serious and uncontrollable abnormalities in the rhythm, conduction or morphology of resting electrocardiogram, such as complete left bundle branch block, heart block above degree ⅱ, ventricular arrhythmia or atrial fibrillation;