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

NCT07504471 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-03-31

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-23
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07504471 on ClinicalTrials.gov