A Phase II Trial of Adebrelimab in Combination With NALIRIFOX for Conversion Therapy in Locally Advanced Pancreatic Cancer
In this study, Adebrelimab combined with NALIRIFOX conversion therapy was performed in subjects with locally advanced pancreatic cancer to evaluate the efficacy and safety of conversion therapy with immunotherapy combined with chemotherapy, followed by different treatment methods such as surgery, continued conversion therapy, and advanced systemic therapy according to different transformation outcomes, to improve the survival benefit of subjects with locally advanced pancreatic cancer.
• Age 18-75 years old;
• Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (preferably histologically confirmed);
• Judged by the investigator to be unresectable locally advanced (unresectable criteria refer to the guidelines for the diagnosis and treatment of pancreatic cancer);
• Total bilirubin ≤ 2 mg/dL (subjects with bile duct stents can be enrolled if bilirubin ≤ 2 mg/dL and no cholangitis after stent placement);
• Have not received previous treatment for pancreatic cancer, including radiotherapy, chemotherapy, surgery, etc;
• Have at least one measurable lesion (per RECIST 1.1 criteria). ECOG score is 0\
⁃ 1 points within 28 days before the first dose, laboratory tests with adequate organ function: Blood routine: WBC ≥3.0×109/L; ANC≥1.5×109/L；PLT≥100×109/L； HGB≥90 g/L; Liver function: AST≤2.5×ULN; ALT≤2.5×ULN； TBIL≤1.5×ULN; Renal function: Cr≤1.5×ULN or CrCl ≥60 mL/min; Coagulation function: INR≤1.5, APTT≤1.5×ULN ; There was no obvious abnormality in ECG.
• Male subjects, as well as females of childbearing potential, must use contraception for 3 months from the start of the first dose to the last use of the study drug.