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 (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT07504471 currently recruiting?
Yes, this trial is currently recruiting patients.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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