NCT07504471

Hepatic Arterial Infusion of Sodium Bicarbonate (NaHCO3) Combined With NASOX Regimen and Programmed Death-1 (PD-1) Inhibitors for Pancreatic Cancer Liver Metastases

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pancreatic Neoplasms
• Hepatic Metastasis of Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	pH-NASOX-Immune Group	Patients receive a combination treatment in 21-day cycles. On Day 1 of each cycle, an interventional procedure is performed via femoral artery catheterization to the hepatic artery, beginning with a pre-treatment of 50-100 mL of 5% Sodium Bicarbonate (NaHCO3) followed by a 5% glucose flush to modulate the tumor microenvironment. This is immediately followed by the NASOX-HAIC regimen, consisting of a 2-hour hepatic arterial infusion of Oxaliplatin (85 mg/m²) and an infusion of Liposomal Irinotecan (70 mg/m²). Before the catheter is removed, a fixed 200 mg dose of a PD-1 inhibitor (Sintilimab, Tislelizumab, or Toripalimab) is administered via intra-arterial injection. To complete the cycle, patients take oral S-1 twice daily from Day 1 to Day 14 (with the dose determined by body surface area), followed by a 7-day rest period.

Timeline

• Start date: 2026-03-23
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2026-03-31
• Last updated: 2026-03-31

Locations

1 site across 1 country: China