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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.

Phase 2RecruitingRuijin HospitalNCT07504471Data as of May 2026

Treatment: pH-NASOX-Immune GroupThis 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.

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Extracted 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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