A Prospective, Single-Center, Phase II Clinical Study of Hepatic Arterial Infusion of Sodium Bicarbonate (NaHCO3) Combined With NASOX Regimen (Liposomal Irinotecan, Oxaliplatin, and S-1) Hepatic Arterial Infusion Chemotherapy (HAIC) and Intra-Arterial Programmed Death-1 (PD-1) Inhibitors for Liver Metastases From Pancreatic Cancer
This Phase II clinical study evaluates the safety and efficacy of a combination therapy for patients with pancreatic cancer that has spread to the liver. Because liver metastases are a major factor in the progression of pancreatic cancer, this research utilizes Hepatic Arterial Infusion Chemotherapy (HAIC) to deliver high-concentration treatment directly into the tumor's blood supply. The multi-step strategy involves first infusing Sodium Bicarbonate to neutralize the acidic tumor microenvironment , followed by the NASOX chemotherapy regimen (Oxaliplatin and Liposomal Irinotecan) and an intra-arterial PD-1 inhibitor to boost immune response. Patients also receive oral S-1 to maintain treatment effect. The primary goal is to determine if this integrated approach can improve Overall Survival for patients compared to historical standard treatments.
• Aged 18 years and above, with no gender restrictions;
• Pathologically confirmed pancreatic cancer (originating from the pancreatic ductal epithelium), with metastasis to the liver;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
• Adequate organ function, meeting the following criteria:
• a. Hematological tests:
⁃ Neutrophils ≥ 1.5 × 10⁹ /L;
⁃ White blood cells ≥ 3.0 × 10⁹ /L;
⁃ Platelets ≥ 85 × 10⁹ /L;
⁃ Hemoglobin ≥ 70 g/L; b. Biochemical tests:
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‣ Total bilirubin ≤ 2× upper limit of normal (ULN) (for subjects with biliary obstruction, after biliary drainage ≤ 2.5 × ULN);
⁃ Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in metastatic subjects ≤ 5 × ULN;
⁃ Albumin level ≥ 28 g/L;
⁃ Creatinine clearance rate ≥ 60 ml/min; c. Cardiac function tests:
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‣ Normal electrocardiogram (ECG) or ECG abnormalities deemed clinically insignificant by the investigator;
⁃ Left ventricular ejection fraction (LVEF) ≥ lower limit of normal;
• At least 3 weeks post-surgery, radiotherapy, chemotherapy, or other anti-tumor treatments, with general physical condition or related adverse reactions having recovered (toxicity ≤ grade 1) or stabilized;
• Willing to participate and sign the informed consent form;
• Good compliance and agreement to cooperate with survival follow-up.