OncoMatch/Clinical Trials/NCT07504471
Hepatic Arterial Infusion of Sodium Bicarbonate (NaHCO3) Combined With NASOX Regimen and Programmed Death-1 (PD-1) Inhibitors for Pancreatic Cancer Liver Metastases
Is NCT07504471 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies pH-NASOX-Immune Group for pancreatic neoplasms.
Treatment: pH-NASOX-Immune Group — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Lab requirements
Blood counts
Neutrophils ≥ 1.5 × 10⁹ /L; White blood cells ≥ 3.0 × 10⁹ /L; Platelets ≥ 85 × 10⁹ /L; Hemoglobin ≥ 70 g/L
Kidney function
Creatinine clearance rate ≥ 60 ml/min
Liver function
Total bilirubin ≤ 2× ULN (≤ 2.5 × ULN after biliary drainage); AST/ALT ≤ 5 × ULN; Albumin ≥ 28 g/L
Cardiac function
Normal ECG or clinically insignificant abnormalities; LVEF ≥ lower limit of normal
Adequate organ function, meeting the following criteria: Hematological tests: Neutrophils ≥ 1.5 × 10⁹ /L; White blood cells ≥ 3.0 × 10⁹ /L; Platelets ≥ 85 × 10⁹ /L; Hemoglobin ≥ 70 g/L; Biochemical tests: Total bilirubin ≤ 2× ULN (for subjects with biliary obstruction, after biliary drainage ≤ 2.5 × ULN); AST/ALT in metastatic subjects ≤ 5 × ULN; Albumin ≥ 28 g/L; Creatinine clearance rate ≥ 60 ml/min; Cardiac function tests: Normal ECG or ECG abnormalities deemed clinically insignificant by the investigator; LVEF ≥ lower limit of normal
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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