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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

ConditionsPancreatic NeoplasmsHepatic Metastasis of Pancreatic Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 years and above, with no gender restrictions;

Pathologically confirmed pancreatic cancer (originating from the pancreatic ductal epithelium), with metastasis to the liver;

Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;

Neutrophils ≥ 1.5 × 10⁹ /L;

Disqualifiers

Subjects with ascites requiring clinical intervention (including moderate to large amounts of ascites; subjects with ascites need to be stable for more than 4 weeks after drainage);

Clinically severe gastrointestinal diseases (including bleeding, infectious inflammation, perforation, obstruction, or diarrhea greater than grade 1);

NRS pain score ≥ 4 after standardized treatment with analgesics;

Second primary malignancy within 5 years (except cured carcinoma in situ, basal cell, or squamous cell skin cancer; subjects with other previous tumors can be enrolled if there has been no recurrence within 5 years);

Trial design

Design model

Single group

Treatments tested in this trial

  • pH-NASOX-Immune Group

    Drug

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Interventional THERAPY GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

Time frame
From the date of first treatment until the date of death from any cause, assessed up to 2 years.

Secondary outcomes

1

Progression-Free Survival (PFS)

Time frame
From enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
2

Objective Response Rate (ORR)

Time frame
From enrollment until the date of first documented progression, assessed up to 2 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ruijin Hospital

Lead sponsor

Source ClinicalTrials.gov
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