Actively Recruiting
Hepatic Arterial Infusion of Sodium Bicarbonate (NaHCO3) Combined With NASOX Regimen and Programmed Death-1 (PD-1) Inhibitors for Pancreatic Cancer Liver Metastases
Led by Ruijin Hospital · Updated on 2026-03-31
50
Participants Needed
1
Research Sites
92 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Hepatic Arterial Infusion of Sodium Bicarbonate (NaHCO3) Combined With NASOX Regimen and Programmed Death-1 (PD-1) Inhibitors for Pancreatic Cancer Liver Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years and above, with no gender restrictions
- Pathologically confirmed pancreatic cancer with liver metastasis
- ECOG performance status score of 0 to 2
- Adequate organ function including neutrophils 5 1.5 �D7 10�B9/L, white blood cells 5 3.0 �D7 10�B9/L, platelets 5 85 �D7 10�B9/L, hemoglobin 5 70 g/L
- Biochemical tests including total bilirubin C= 2�D7 upper limit of normal (ULN), AST and ALT C= 5 �D7 ULN, albumin 5 28 g/L, creatinine clearance rate 5 60 ml/min
- Cardiac function tests with normal ECG or clinically insignificant abnormalities and left ventricular ejection fraction 5 lower limit of normal
- At least 3 weeks post surgery, radiotherapy, chemotherapy, or other anti-tumor treatments with recovery or stabilized adverse reactions
- Willing to participate and sign informed consent
- Good compliance and agreement to cooperate with survival follow-up
You will not qualify if you...
- Ascites requiring clinical intervention or unstable after drainage
- Clinically severe gastrointestinal diseases including bleeding, infectious inflammation, perforation, obstruction, or diarrhea greater than grade 1
- NRS pain score E= 4 after standardized analgesic treatment
- Second primary malignancy within 5 years except certain cured skin cancers
- Uncontrolled cardiovascular or cerebrovascular diseases including NYHA class III or higher heart failure, unstable angina, recent myocardial infarction or stroke, arrhythmias requiring treatment, uncontrolled hypertension
- Known active hepatitis B infection
- Active infection or unexplained fever above 38.5�B0C during screening or treatment day, unless tumor-related fever
- Pregnant or breastfeeding women
- Women of childbearing potential with positive pregnancy test during screening
- Other medical or social issues affecting consent, participation, or result interpretation
- Estimated survival time of 3 months or less
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Radiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 2000010
Actively Recruiting
Research Team
Z
Zhongmin Wang
CONTACT
X
Xiaoyu Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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