Pancreatic Ductal AdenocarcinomaPhase 4NCT05634720
Hepatic Artery Chemotherapy for Patients With Localized Pancreas Cancer
A Phase 4 study testing HA Chemotherapy in people with Pancreatic Ductal Adenocarcinoma, run by Duke University at 1 site in United States.
Trial summary
This is a window-of-opportunity study which will evaluate the safety and feasibility of single-dose neoadjuvant Hepatic Artery (HA) chemotherapy (FUDR/oxaliplatin) in patients with localized pancreatic ductal adenocarcinoma (PDAC) eligible for surgical resection and systemic chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- HA Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2024to 31 Dec 2028
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Patients are eligible to be included in the study only if they meet all of the following criteria:
- Histologically or cytologically confirmed diagnosis of PDAC, which is clinically staged as either resectable or borderline resectable after multidisciplinary evaluation.
- Age >= 18 yo
- ECOG Performance Status 0-1
- Eligibility for FOLFIRINOX as determined by medical oncology.
- Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device) during the study and must have a negative serum or urine pregnancy test within 1 week of neoadjuvant HA chemotherapy as well as during adjuvant chemotherapy as per SOC practices.
Show all 16Show fewer
- Fertile men must practice effective contraceptive methods during the study, unless documentation of infertility exists.
- Expected survival >3 months.
- Adequate laboratory parameters and organ function, namely:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelets ≥ 100 x 109/L
- Hemoglobin (Hgb) ≥ 8 g/dL
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- ALT and AST ≤ 2.5 x ULN
- Serum creatinine ≤ 1.5 x ULN or creatinine clearance (estimated) ≥ 50 cc/min by Cockroft-Gault Formula (Appendix C)
- Provide written, informed consent to participate in the study and follow the study procedures.
Who cannot join
- Patients will be excluded from the study if they meet any of the following criteria:
- Hepatic arterial anatomy not amenable to percutaneous access, and/or delivery of HA chemotherapy, as determined by the principal investigator and treating interventional radiologist. These may include any of the following: celiac or superior mesenteric artery occlusion; accessory or replaced hepatic arteries that cannot be ligated, divided, or embolized per the treating surgeon/interventional radiologist and would thus require more than two hepatic artery branch cannulations to treat the entire liver; any other variant anatomy deemed to have a risk of non-target GI infusion or incomplete hepatic perfusion.
- CA 19-9 >500 within 4 weeks of planned surgical resection.
- Pregnancy or breastfeeding.
- Not willing to use an effective method of birth control.
- History of other carcinomas diagnosed within the last two years, except cured non-melanoma skin cancer, curatively treated in-situ cervical cancer, curatively treated localized thyroid cancer, or localized prostate cancer treated curatively with no evidence of biochemical or imaging recurrence.
Show all 22Show fewer
- Liver cirrhosis.
- Prior liver surgery including partial hepatectomy or transplantation.
- Active hepatitis or unresolved biliary obstruction at the time of diagnostic laparoscopy, as evidenced by:
- Total bilirubin > 1.5 x ULN
- ALT and AST > 2.5 x ULN
- Recent or current active infectious disease requiring systemic antivirals, antibiotics or antifungals, or treatment within 2 weeks prior to the start of study drug, including acute or chronic active hepatitis B or hepatitis C infection, or uncontrolled HIV/AIDS. Patients with well controlled HIV are permitted. Patients receiving prophylactic antibiotics (e.g., for prevention of urinary tract infection or chronic obstructive pulmonary disease) are eligible.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to the start of study or anticipation of need for major surgical procedure during the course of the study other than surgical resection of the pancreatic tumor.
- Serious, non-healing wound, ulcer, or bone fracture.
- History of allogenic hematopoietic stem cell transplantation.
- Known hepatitis B virus (HBV) infection (e.g., positive hepatitis B surface antigen [HBsAg]) or hepatitis C virus (HCV) infection (e.g., positive HCV ribonucleic acid [RNA]).
- Chronic treatment with systemic corticosteroids (> 10 mg daily prednisone equivalents) or immunosuppressive medications
- Intermittent steroids (< 10 mg daily prednisone equivalents) may be used on an as needed basis (e.g. for treatment of nausea, anorexia, and fatigue)
- Physiologic replacement doses of steroids due to adrenal insufficiency are permitted in the absence of active autoimmune disease.
- Topical, inhaled, or intra-articular corticosteroids are allowed.
- Participation in other interventional research protocols during the screening to 30 day follow up time-point.
- Concurrent severe and/or uncontrolled medical conditions, which may compromise participation in the study, including impaired heart function or clinically significant heart disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27710
About this study
Official title: A Window-of-Opportunity Trial Using Neoadjuvant Hepatic Artery Chemotherapy for Patients With Localized Pancreas Cancer
This is a window-of-opportunity study which will evaluate the safety and feasibility of single-dose neoadjuvant Hepatic Artery (HA) chemotherapy (FUDR/oxaliplatin) in patients with localized pancreatic ductal adenocarcinoma (PDAC) eligible for surgical resection and systemic chemotherapy.
Current standard-of-care therapy for patients with localized PDAC includes surgical resection and six months of systemic chemotherapy. Because the sequence of these treatments (surgery and chemotherapy) is not well established, we will include both patients planned to undergo surgery before chemotherapy, as well as patients planned to receive systemic chemotherapy before surgery. This will allow us to test the safety and feasibility of adding single-dose neoadjuvant HA chemotherapy prior to surgery across the real-world treatment strategies employed in typical clinical practice. Moreover, the window-of-opportunity design is intended to make sure that all patients receive HA chemotherapy in addition to standard-of-care surgery and systemic chemotherapy, so as not to withhold the treatment approach currently associated with best outcomes.
The primary endpoint is safety and feasibility, and patients will be followed for 30 days after resection of their primary tumors to assess these outcomes. Following the short-term follow-up period, patients move to long-term follow-up, which will occur every three months after resection of the primary tumor, for a period of up to three years. Long-term secondary endpoints include disease free survival (DFS), liver metastasis-free survival (LMFS), and overall survival (OS).
Read the detailed description
This window-of-opportunity study will evaluate the safety and feasibility of single-dose neoadjuvant HA chemotherapy (FUDR/oxaliplatin) in patients with localized PDAC eligible for surgical resection and systemic chemotherapy. Current standard-of-care therapy for patients with localized PDAC includes surgical resection and six months of systemic chemotherapy. Because the sequence of these treatments (surgery and chemotherapy) is not well established, we will include both patients planned to undergo surgery before chemotherapy, as well as patients planned to receive systemic chemotherapy before surgery. This will allow us to test the safety and feasibility of adding single-dose neoadjuvant HA chemotherapy prior to surgery across the real-world treatment strategies employed in typical clinical practice. Moreover, the window-of-opportunity design is intended to make sure that all patients receive HA chemotherapy in addition to standard-of-care surgery and systemic chemotherapy, so as not to withhold the treatment approach currently associated with best outcomes.
During an initial screening period (0 to 28 days before the treatment period), informed consent will be obtained and all inclusion/exclusion criteria will be confirmed for participation. Once deemed appropriate for participation, patients will be enrolled and begin study treatment. On Day 1 of the treatment period, patients will undergo standard-of-care diagnostic laparoscopy to confirm the absence of metastatic disease not seen on staging imaging, as well as tissue acquisition (blood and liver biopsies) for pre-specified correlative scientific studies. On Day 2 (±1 day), patients will receive the interventional treatment, which is neoadjuvant HA chemotherapy. On Day 14 (±5 business days), patients will undergo standard-of-care resection of their primary tumor, as well as tissue acquisition (blood, liver biopsies, primary tumor, regional lymph nodes) for pre-specified correlative scientific studies.
The primary endpoint is safety and feasibility, and patients will be followed for 30 days after resection of their primary tumors to assess these outcomes. This includes safety evaluations on treatment period Day 1 (diagnostic laparoscopy), Day 2 (±1 day, HA chemotherapy), Day 4 (+2 business days), Day 14 (±5 business days, day of primary tumor resection), every day throughout the perioperative hospitalization, and at outpatient follow-up (30 days ±10 business days after surgery for resection of the primary tumor).
Following the short-term follow-up period, patients move to long-term follow-up, which will occur every three months (±20 business days) after resection of the primary tumor, for a period of up to three years. Long-term secondary endpoints include DFS, LMFS, and OS.
As mentioned, a biobanking effort is built into this study to support prespecified correlative scientific objectives. This includes acquisition of peripheral blood and liver biopsies at the time of diagnostic laparoscopy (Day 1), acquisition of peripheral blood, liver biopsies, the primary tumor, and regional lymph nodes at the time of resection of the primary tumor (Day 14 ±5 days), and acquisition of peripheral blood at outpatient follow-up appointments. Correlative studies include multisite immune profiling, assessment of the HOMB both before and after HA chemotherapy, and dynamic assessment of ctDNA.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- HA Chemotherapy
- Keywords
- PDAC, HA chemotherapy, FUDR, oxaliplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HA ChemotherapyDrug
Patients will receive the interventional treatment, which is neoadjuvant HA chemotherapy (FUDR/oxaliplatin delivered via the Hepatic Artery).
| Study group | Role | What they receive |
|---|---|---|
| PDAC with HA Chemotherapy | Experimental | Patients eligible to receive systemic chemotherapy and surgical resection will have the investigational treatment, which is neoadjuvant HA chemotherapy prior to resection. Receives: Drug: HA Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of HA (Hepatic Artery) Chemotherapy for PDAC (Pancreatic Ductal Adenocarcinoma)
The safety of HA (Hepatic Artery) chemotherapy for PDAC (pancreatic ductal adenocarcinoma) will be interpreted as the total number of adverse events experienced for all patients who received HA chemotherapy from the time of consent through 30 days after surgery for resection of the primary tumor.
Measured: 30 days postoperatively
Feasibility of HA Chemotherapy for PDAC
The primary aim of feasibility of this prospective single arm study will be assessed based on patient recruitment, retention rates, safety, and side effects. These rates will be estimated along with 95% confidence intervals. We will report the number of participants who received HA chemotherapy followed by planned standard-of-care surgical resection.
Measured: 30 days post-operatively
Secondary outcomes (3)
Disease Free Survival
Long-term follow-up will occur at standard-of-care surveillance intervals of every three months until 3 years post-operation for disease recurrence.
Measured: 3 years of post-operative surveillance
Liver Metastasis-free Survival
Long-term follow-up will occur at standard-of-care surveillance intervals of every three months for 3 years post-operation to determine liver metastasis free survival.
Measured: 3 years of post-operative surveillance
Overall Survival
Long-term follow-up will occur at standard-of-care surveillance intervals of every three months for three years post-operation until death or study closure.
Measured: 3 years of post-operative surveillance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start2 Jan 2024
- Primary completion18 Nov 2025
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Duke 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- We will include both patients planned to undergo surgery before chemotherapy, as well as patients planned to receive systemic chemotherapy before surgery. This will allow us to test the safety and feasibility of adding single-dose neoadjuvant HA chemotherapy prior to surgery across the real-world treatment strategies employed in typical clinical practice. All patients receive HA chemotherapy in addition to standard-of-care surgery and systemic chemotherapy, so as not to withhold the treatment approach currently associated with best outcomes.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Nussbaum, MD, Principal investigator, Duke Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05634720
- Sponsor's protocol ID
- Pro00112285
- Status last verified
- Sep 2026
- First submitted
- 22 Nov 2022
- Last updated
- 15 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon completion of the project, we wish to make our cohort available as well as the coding and instructions for our analysis for replication purposes. The Duke Research Data Repository (RDR) will be used for this purpose. The Duke RDR is an openly accessible preservation archive maintained by the Duke University Libraries. The data will be preserved in the RDR for the long-term according to RDR policies and procedures. The RDR provides for automated backup of all data, which provides an added layer of protection and security for the data.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Window-of-Opportunity Trial Using Neoadjuvant Hepatic Artery Chemotherapy for Patients With Localized Pancreas Cancer
- ClinicalTrials.gov ID
- NCT05634720
- Acronym / sponsor ID
- Pro00112285
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Keywords
- PDAC, HA chemotherapy, FUDR, oxaliplatin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 18 Nov 2025 (actual)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Dec 2022 (actual)
- Results
- Posted 15 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a window-of-opportunity study which will evaluate the safety and feasibility of single-dose neoadjuvant Hepatic Artery (HA) chemotherapy (FUDR/oxaliplatin) in patients with localized pancreatic ductal adenocarcinoma (PDAC) eligible for surgical resection and systemic chemotherapy.
Current standard-of-care therapy for patients with localized PDAC includes surgical resection and six months of systemic chemotherapy. Because the sequence of these treatments (surgery and chemotherapy) is not well established, we will include both patients planned to undergo surgery before chemotherapy, as well as patients planned to receive systemic chemotherapy before surgery. This will allow us to test the safety and feasibility of adding single-dose neoadjuvant HA chemotherapy prior to surgery across the real-world treatment strategies employed in typical clinical practice. Moreover, the window-of-opportunity design is intended to make sure that all patients receive HA chemotherapy in addition to standard-of-care surgery and systemic chemotherapy, so as not to withhold the treatment approach currently associated with best outcomes.
The primary endpoint is safety and feasibility, and patients will be followed for 30 days after resection of their primary tumors to assess these outcomes. Following the short-term follow-up period, patients move to long-term follow-up, which will occur every three months after resection of the primary tumor, for a period of up to three years. Long-term secondary endpoints include disease free survival (DFS), liver metastasis-free survival (LMFS), and overall survival (OS).
Detailed description
This window-of-opportunity study will evaluate the safety and feasibility of single-dose neoadjuvant HA chemotherapy (FUDR/oxaliplatin) in patients with localized PDAC eligible for surgical resection and systemic chemotherapy. Current standard-of-care therapy for patients with localized PDAC includes surgical resection and six months of systemic chemotherapy. Because the sequence of these treatments (surgery and chemotherapy) is not well established, we will include both patients planned to undergo surgery before chemotherapy, as well as patients planned to receive systemic chemotherapy before surgery. This will allow us to test the safety and feasibility of adding single-dose neoadjuvant HA chemotherapy prior to surgery across the real-world treatment strategies employed in typical clinical practice. Moreover, the window-of-opportunity design is intended to make sure that all patients receive HA chemotherapy in addition to standard-of-care surgery and systemic chemotherapy, so as not to withhold the treatment approach currently associated with best outcomes.
During an initial screening period (0 to 28 days before the treatment period), informed consent will be obtained and all inclusion/exclusion criteria will be confirmed for participation. Once deemed appropriate for participation, patients will be enrolled and begin study treatment. On Day 1 of the treatment period, patients will undergo standard-of-care diagnostic laparoscopy to confirm the absence of metastatic disease not seen on staging imaging, as well as tissue acquisition (blood and liver biopsies) for pre-specified correlative scientific studies. On Day 2 (±1 day), patients will receive the interventional treatment, which is neoadjuvant HA chemotherapy. On Day 14 (±5 business days), patients will undergo standard-of-care resection of their primary tumor, as well as tissue acquisition (blood, liver biopsies, primary tumor, regional lymph nodes) for pre-specified correlative scientific studies.
The primary endpoint is safety and feasibility, and patients will be followed for 30 days after resection of their primary tumors to assess these outcomes. This includes safety evaluations on treatment period Day 1 (diagnostic laparoscopy), Day 2 (±1 day, HA chemotherapy), Day 4 (+2 business days), Day 14 (±5 business days, day of primary tumor resection), every day throughout the perioperative hospitalization, and at outpatient follow-up (30 days ±10 business days after surgery for resection of the primary tumor).
Following the short-term follow-up period, patients move to long-term follow-up, which will occur every three months (±20 business days) after resection of the primary tumor, for a period of up to three years. Long-term secondary endpoints include DFS, LMFS, and OS.
As mentioned, a biobanking effort is built into this study to support prespecified correlative scientific objectives. This includes acquisition of peripheral blood and liver biopsies at the time of diagnostic laparoscopy (Day 1), acquisition of peripheral blood, liver biopsies, the primary tumor, and regional lymph nodes at the time of resection of the primary tumor (Day 14 ±5 days), and acquisition of peripheral blood at outpatient follow-up appointments. Correlative studies include multisite immune profiling, assessment of the HOMB both before and after HA chemotherapy, and dynamic assessment of ctDNA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- We will include both patients planned to undergo surgery before chemotherapy, as well as patients planned to receive systemic chemotherapy before surgery. This will allow us to test the safety and feasibility of adding single-dose neoadjuvant HA chemotherapy prior to surgery across the real-world treatment strategies employed in typical clinical practice. All patients receive HA chemotherapy in addition to standard-of-care surgery and systemic chemotherapy, so as not to withhold the treatment approach currently associated with best outcomes.
| Arm | Type | Receives |
|---|---|---|
| PDAC with HA Chemotherapy | Experimental | Drug: HA ChemotherapyPatients eligible to receive systemic chemotherapy and surgical resection will have the investigational treatment, which is neoadjuvant HA chemotherapy prior to resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients are eligible to be included in the study only if they meet all of the following criteria:
- Histologically or cytologically confirmed diagnosis of PDAC, which is clinically staged as either resectable or borderline resectable after multidisciplinary evaluation.
- Age >= 18 yo
- ECOG Performance Status 0-1
- Eligibility for FOLFIRINOX as determined by medical oncology.
Key exclusion criteria (22 listed)
- Hepatic arterial anatomy not amenable to percutaneous access, and/or delivery of HA chemotherapy, as determined by the principal investigator and treating interventional radiologist. These may include any of the following: celiac or superior mesenteric artery occlusion; accessory or replaced hepatic arteries that cannot be ligated, divided, or embolized per the treating surgeon/interventional radiologist and would thus require more than two hepatic artery branch cannulations to treat the entire liver; any other variant anatomy deemed to have a risk of non-target GI infusion or incomplete hepatic perfusion.
- CA 19-9 >500 within 4 weeks of planned surgical resection.
- Pregnancy or breastfeeding.
- Not willing to use an effective method of birth control.
- History of other carcinomas diagnosed within the last two years, except cured non-melanoma skin cancer, curatively treated in-situ cervical cancer, curatively treated localized thyroid cancer, or localized prostate cancer treated curatively with no evidence of biochemical or imaging recurrence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HA ChemotherapyPatients will receive the interventional treatment, which is neoadjuvant HA chemotherapy (FUDR/oxaliplatin delivered via the Hepatic Artery). | Drug | PDAC with HA Chemotherapy |
Primary outcome
Safety of HA (Hepatic Artery) Chemotherapy for PDAC (Pancreatic Ductal Adenocarcinoma)
Time frame: 30 days postoperatively
The safety of HA (Hepatic Artery) chemotherapy for PDAC (pancreatic ductal adenocarcinoma) will be interpreted as the total number of adverse events experienced for all patients who received HA chemotherapy from the time of consent through 30 days after surgery for resection of the primary tumor.
Feasibility of HA Chemotherapy for PDAC
Time frame: 30 days post-operatively
The primary aim of feasibility of this prospective single arm study will be assessed based on patient recruitment, retention rates, safety, and side effects. These rates will be estimated along with 95% confidence intervals. We will report the number of participants who received HA chemotherapy followed by planned standard-of-care surgical resection.
3 secondary outcomes
Disease Free Survival
Time frame: 3 years of post-operative surveillance
Liver Metastasis-free Survival
Time frame: 3 years of post-operative surveillance
Overall Survival
Time frame: 3 years of post-operative surveillance
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Upon completion of the project, we wish to make our cohort available as well as the coding and instructions for our analysis for replication purposes. The Duke Research Data Repository (RDR) will be used for this purpose. The Duke RDR is an openly accessible preservation archive maintained by the Duke University Libraries. The data will be preserved in the RDR for the long-term according to RDR policies and procedures. The RDR provides for automated backup of all data, which provides an added layer of protection and security for the data.
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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.
Daniel Nussbaum, MD principal investigator
Duke Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing HA Chemotherapy in people with Pancreatic Ductal Adenocarcinoma, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 22 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 15 Oct 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety of HA (Hepatic Artery) Chemotherapy for PDAC (Pancreatic Ductal Adenocarcinoma) (time frame: 30 days postoperatively). The study lists 2 primary outcomes in all. 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 15 Oct 2026.