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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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 Irinoteca

Первичные конечные точки

• Overall Survival (OS) [Срок оценки: From the date of first treatment until the date of death from any cause, assessed up to 2 years.]

Вторичные конечные точки (2)

• Progression-Free Survival (PFS) [Срок оценки: From enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.]
• Objective Response Rate (ORR) [Срок оценки: From enrollment until the date of first documented progression, assessed up to 2 years.]

Критерии участия

Критерии включения

• 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;
• Adequate organ function, meeting the following criteria:

a. Hematological tests:

• Neutrophils ≥ 1.5 × 10⁹ /L;
• White blood cells ≥ 3.0 × 10⁹ /L;
• Platelets ≥ 85 × 10⁹ /L;
• Hemoglobin ≥ 70 g/L; b. Biochemical tests:

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• Total bilirubin ≤ 2× upper limit of normal (ULN) (for subjects with biliary obstruction, after biliary drainage ≤ 2.5 × ULN);
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in metastatic subjects ≤ 5 × ULN;
• Albumin level ≥ 28 g/L;
• Creatinine clearance rate ≥ 60 ml/min; c. Cardiac function tests:

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• Normal electrocardiogram (ECG) or ECG abnormalities deemed clinically insignificant by the investigator;
• Left ventricular ejection fraction (LVEF) ≥ lower limit of normal;
• At least 3 weeks post-surgery, radiotherapy, chemotherapy, or other anti-tumor treatments, with general physical condition or related adverse reactions having recovered (toxicity ≤ grade 1) or stabilized;
• Willing to participate and sign the informed consent form;
• Good compliance and agreement to cooperate with survival follow-up.

Критерии исключения

• 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);
• Uncontrolled cardiovascular or cerebrovascular diseases with clinical symptoms, including but not limited to: ① NYHA class III or higher heart failure; ② unstable angina; ③ myocardial infarction or stroke within 6 months; ④ supraventricular or ventricular arrhythmias requiring treatment or intervention; ⑤ uncontrolled hypertension (systolic blood pressure \&gt; 150 mmHg and/or diastolic blood pressure \&gt; 90 mmHg despite optimal treatment);
• Known active hepatitis B subjects (HBsAg positive and HBV DNA ≥ 10³ copies or ≥ 1000 U/ml);
• Active infection or unexplained fever \&gt; 38.5°C during the screening period or on the day of administration (subjects with fever caused by tumors can be enrolled as judged by the investigator), which, in the investigator\&#39;s judgment, would affect the subject\&#39;s participation in this trial or interfere with the evaluation of efficacy;
• Pregnant or breastfeeding women;
• Women of childbearing potential with a positive blood (urine) pregnancy test during the screening period (both male and female subjects should use reliable contraception during the trial and for 3 months after the last dose to prevent pregnancy);
• Subjects with other medical or social issues that, in the investigator\&#39;s judgment, might affect their ability to sign informed consent, participation in the trial, or interpretation of the trial results;
• Patients with an estimated survival time of ≤ 3 months are not included in this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Department of Radiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Шанхай

Идентификаторы

NCT: NCT07504471 · 2026-64

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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