Pancreatic Cancer (Unresectable)SAIC-PBTCNCT07497204
Splenic Artery Infusion Chemotherapy vs Systemic Chemotherapy in Advanced Pancreatic Body/Tail Cancer
An observational study of Pancreatic Cancer (Unresectable), run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer (Unresectable)
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
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;
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
About this study
Official title: 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.
Read more
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.
Read the 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)
- Keywords
- Splenic Artery Infusion Chemotherapy, SAIC, Pancreatic Body and Tail Cancer, Regional Intra-arterial Chemotherapy, Systemic Chemotherapy, Advanced Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
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.
Measured: From the start of treatment until death or the last follow-up visit; the follow-up cutoff date is December 31, 2025
Secondary outcomes (1)
Progression-Free Survival (PFS)
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.
Measured: From the start of treatment until disease progression or death; the follow-up cutoff date is December 31, 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Jan 2020
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer (Unresectable)Studies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China, Sun Yat-sen University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497204
- Sponsor's protocol ID
- SYSKY-2026-160-01
- Other IDs
- 82273476
- Acronym
- SAIC-PBTC
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Splenic Artery Infusion Chemotherapy Compared With Systemic Chemotherapy in Advanced Pancreatic Body/Tail Cancer: A Real-World Study
- ClinicalTrials.gov ID
- NCT07497204
- Acronym / sponsor ID
- SAIC-PBTC / SYSKY-2026-160-01
- Conditions
- Pancreatic Cancer (Unresectable)
- Keywords
- Splenic Artery Infusion Chemotherapy, SAIC, Pancreatic Body and Tail Cancer, Regional Intra-arterial Chemotherapy, Systemic Chemotherapy, Advanced Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China, Sun Yat-sen University
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer (Unresectable), run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.