Splenic Artery Infusion Chemotherapy vs Systemic Chemotherapy in Advanced Pancreatic Body/Tail Cancer (SAIC-PBTC)

March 23, 2026 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

A total of 60 patients with advanced pancreatic body/tail adenocarcinoma treated between January 2020 and December 2024 were enrolled in this real-world study, including 25 patients who received splenic artery infusion chemotherapy (SAIC) and 35 patients who received systemic chemotherapy.

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From the start of treatment until death or the last follow-up visit; the follow-up cutoff date is December 31, 2025
Overall 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.
From the start of treatment until death or the last follow-up visit; the follow-up cutoff date is December 31, 2025

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: From the start of treatment until disease progression or death; the follow-up cutoff date is December 31, 2025
Progression-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.
From the start of treatment until disease progression or death; the follow-up cutoff date is December 31, 2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Collaborators

National Natural Science Foundation of China
Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSKY-2026-160-01
  • 82273476 (Other Grant/Funding Number: National Natural Science Foundation of China)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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