Hepatic Arterial Infusion of Sodium Bicarbonate (NaHCO3) Combined With NASOX Regimen and P
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 h
| Condition(s) | Pancreatic Neoplasms, Hepatic Metastasis of Pancreatic Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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 |
| Who can participate | Inclusion Criteria: * 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: 1. Neutrophils ≥ 1.5 × 10⁹ /L; 2. White blood cells ≥ 3.0 × 10⁹ /L; 3. Platelets ≥ 85 × 10⁹ /L; 4. Hemoglobin ≥ 70 g/L; b. Biochemical tests: <!-- --> 1. Total bilirubin ≤ 2× upper limit of normal (ULN) (for subjects with biliary obstruction, after biliary drainage ≤ 2.5 × ULN); 2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in metastatic subjects ≤ 5 × ULN; 3. Albumin level ≥ 28 g/L; 4. Creatinine clearan |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Ruijin Hospital |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2026-03-23 |
| NCT ID | NCT07504471 |
| Official listing | https://clinicaltrials.gov/study/NCT07504471 |