NCT07497204

Splenic Artery Infusion Chemotherapy vs Systemic Chemotherapy in Advanced Pancreatic Body/Tail Cancer

Efficacy and Safety of Splenic Artery Infusion Chemotherapy Compared With Systemic Chemotherapy in Advanced Pancreatic Body/Tail Cancer: A Real-World Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Pancreatic body and tail cancers are frequently diagnosed at an advanced stage and are associated with poor prognosis. Systemic chemotherapy remains the standard treatment for unresectable advanced pancreatic cancer, but its effectiveness is often limited by systemic toxicity and suboptimal intratumoral drug concentration. Splenic artery infusion chemotherapy (SAIC) is a regional treatment strategy that delivers chemotherapeutic agents directly into the arterial supply of the pancreatic body and tail, potentially increasing local drug concentration while reducing systemic exposure. However, clinical evidence comparing SAIC with conventional systemic chemotherapy in patients with advanced pancreatic body and tail cancer remains limited. This retrospective real-world study aims to compare the efficacy and safety of SAIC and systemic chemotherapy in patients with advanced pancreatic body/tail cancer treated at Sun Yat-sen Memorial Hospital. Clinical data from patients treated between January 2020 and December 2024 will be analyzed. Survival outcomes including overall survival (OS) and progression-free survival (PFS), radiological tumor response, biochemical response, surgical conversion rate, and treatment-related adverse events will be evaluated. The findings of this study may provide evidence to support the potential clinical value of splenic artery infusion chemotherapy as an alternative treatment strategy for patients with advanced pancreatic body/tail cancer.

Detailed description

Pancreatic cancer is one of the most lethal malignancies worldwide, with a five-year survival rate of less than 10%. Tumors arising from the pancreatic body and tail account for approximately 30-40% of pancreatic cancers and are often diagnosed at an advanced stage because of their deep anatomical location and lack of early symptoms. For patients with unresectable or metastatic pancreatic cancer, systemic chemotherapy remains the cornerstone of treatment. However, the clinical benefits of systemic chemotherapy are frequently limited by treatment-related toxicity and inadequate intratumoral drug concentrations. Regional intra-arterial chemotherapy has been proposed as a strategy to improve drug delivery to pancreatic tumors. By administering chemotherapeutic agents directly into tumor-feeding arteries, higher local drug concentrations can be achieved while reducing systemic exposure. The splenic artery represents the primary arterial supply to the pancreatic body and tail, making it a rational route for regional drug delivery in tumors located in this region. Splenic artery infusion chemotherapy (SAIC) therefore has the potential to improve tumor control and reduce systemic toxicity in patients with advanced pancreatic body/tail cancer. Despite the anatomical rationale and promising preliminary evidence, direct clinical comparisons between SAIC and standard systemic chemotherapy in patients with advanced pancreatic body/tail cancer remain limited. Therefore, this study aims to evaluate the efficacy and safety of SAIC compared with systemic chemotherapy in a real-world clinical setting. This study is a single-center retrospective observational study conducted at the Department of Biliary-Pancreatic Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University. Patients with advanced pancreatic body/tail cancer who received SAIC or systemic chemotherapy between January 2020 and December 2024 were included. The primary outcome of the study is overall survival (OS), and the secondary outcome is progression-free survival (PFS). Additional outcomes include radiological tumor response evaluated according to RECIST criteria, changes in serum CA19-9 levels, surgical conversion rate after treatment, and treatment-related adverse events graded according to the Common Terminology Criteria for Adverse Events (CTCAE). Through this retrospective analysis, the study aims to provide clinical evidence regarding the potential benefits of splenic artery infusion chemotherapy in improving survival outcomes and safety profiles for patients with advanced pancreatic body/tail cancer.

Conditions

• Pancreatic Cancer (Unresectable)

Timeline

• Start date: 2020-01-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: China