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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07497204
Acronym
SAIC-PBTC
Enrollment
60
Registered
2026-03-27
Start date
2020-01-01
Completion date
2025-12-31
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer (Unresectable)

Keywords

Splenic Artery Infusion Chemotherapy, SAIC, Pancreatic Body and Tail Cancer, Regional Intra-arterial Chemotherapy, Systemic Chemotherapy, Advanced Pancreatic Cancer

Brief 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.

Interventions

None listed

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead SponsorOTHER
National Natural Science Foundation of China
CollaboratorOTHER_GOV
Sun Yat-sen University
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Age ≥ 18 years; Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; Pathologically confirmed locally advanced adenocarcinoma originating from the body or tail of the pancreas, or carcinoma with oligometastases to the liver; Adequate baseline organ and bone marrow function;

Exclusion criteria

Presence of other concurrent malignant tumors or autoimmune diseases; Receipt of fewer than two cycles of SAIC/systemic chemotherapy; Incomplete clinical data or loss to follow-up;

Design outcomes

Primary

MeasureTime frameDescription
Overall Survival (OS)From the start of treatment until death or the last follow-up visit; the follow-up cutoff date is December 31, 2025Overall survival (OS) was defined as the time interval from the first administration of splenic artery infusion chemotherapy (SAIC) or systemic chemotherapy to death from any cause or the date of last follow-up.

Secondary

MeasureTime frameDescription
Progression-Free Survival (PFS)From the start of treatment until disease progression or death; the follow-up cutoff date is December 31, 2025Progression-free survival (PFS) was defined as the time interval from the start of treatment to the first disease progression (imaging/clinically confirmed) or death from any cause.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026