Pancreas CancerPhase 1NCT03484299
Chemotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma
A Phase 1 study testing Irreversible Electroporation (IRE), Gemcitabine and FOLFIRINOX in people with Pancreas Cancer, run by University of Louisville at 1 site in United States.
Trial summary
Compare the efficacy and tolerability of IRE in combination with either FOLFIRINOX or gemcitabine in patients with locally advanced pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- Irreversible Electroporation (IRE), Gemcitabine and FOLFIRINOX
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2018to 31 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- greater than or equal to 18 years of age
- diagnosed with stage III pancreatic cancer
- tumor is measurable
- GFR > mL/min/1.73m2
- willing and able to comply with protocol requirements
- AST/ALT >3 times upper limit of normal
- stable surgical post-operative course as defined by operative surgeon
Who cannot join
- participating in another clinical trial for the treatment of cancer at the time of screening
- pregnant or currently breast feeding
- have a cardiac pacemaker or ICD implanted that cannot be deactivated during IRE procedure
- have non-removable implants with metal parts within 1 cm of the target lesion
- had a myocardial infarction within 3 months prior to enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Louisville
Louisville, Kentucky, 40202
Robert Martin, MD, PhD, 502-629-3355, robert.martin@louisville.edu
Robert Martin, MD, PhD
About this study
Official title: Chemotherapy and Irreversible Electroporation (IRE) in the Treatment of Advanced Pancreatic Adenocarcinoma
Compare the efficacy and tolerability of IRE in combination with either FOLFIRINOX or gemcitabine in patients with locally advanced pancreatic cancer.
Read the detailed description
Phase II study in which all patients undergoing IRE for the treatment of locally advanced pancreatic carcinoma will receive either FOLFIRINOX or gemcitabine as peri-ablation treatment.
- Conditions
- Pancreas Cancer
- Being tested
- Irreversible Electroporation (IRE), Gemcitabine, FOLFIRINOX
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irreversible Electroporation (IRE)Procedure or surgery
Non-thermal ablation of tumor
GemcitabineDrug
25% dose - first 3 enrolled; 50% dose - next 3 enrolled; 75% dose - remaining 4 enrolled
FOLFIRINOXDrug
25% dose - first 3 enrolled; 50% dose - next 3 enrolled; 75% dose - remaining 4 enrolled
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | Irreversible electroporation and treatment with either FOLFIRINOX or Gemcitabine (based upon which chemotherapy regimen received prior to IRE) Receives: Procedure: Irreversible Electroporation (IRE); Drug: Gemcitabine; Drug: FOLFIRINOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse and Serious Adverse events will be captured (safety and tolerability)
Adverse and Serious Adverse events will be collected and analyzed
Measured: Time from first dose until subject has reached 90 days post last active study treatment
Secondary outcomes (1)
Progression free survival
Triphase CT scan will be performed within one month of IRE procedure. Triphase CT scans will then be obtained every 3 months to check disease status.
Measured: Time from first dose date to first date of confirmed disease progression, assessed for 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start30 May 2018
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects undergoing IRE will receive treatment with either FOLFIRINOX or gemcitabine (based on which regimen was received prior to IRE)
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert C. Martin, University of Louisville
- Investigators
- Robert Martin, MD, PhD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484299
- Sponsor's protocol ID
- 17.0529
- Status last verified
- Oct 2025
- First submitted
- 13 Feb 2018
- Last updated
- 29 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Bhutiani N, Li Y, Zheng Q, Pandit H, Shi X, Chen Y, Yu Y, Pulliam ZR, Tan M, Martin RCG 2nd. Electrochemotherapy with Irreversible Electroporation and FOLFIRINOX Improves Survival in Murine Models of Pancreatic Adenocarcinoma. Ann Surg Oncol. 2020 Oct;27(11):4348-4359. doi: 10.1245/s10434-020-08782-2. Epub 2020 Jul 17.
PubMed 32681477
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy and Irreversible Electroporation (IRE) in the Treatment of Advanced Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT03484299
- Acronym / sponsor ID
- 17.0529
- Conditions
- Pancreas Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 30 May 2018 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 30 Mar 2018 (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.
Compare the efficacy and tolerability of IRE in combination with either FOLFIRINOX or gemcitabine in patients with locally advanced pancreatic cancer.
Detailed description
Phase II study in which all patients undergoing IRE for the treatment of locally advanced pancreatic carcinoma will receive either FOLFIRINOX or gemcitabine as peri-ablation treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects undergoing IRE will receive treatment with either FOLFIRINOX or gemcitabine (based on which regimen was received prior to IRE)
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Procedure: Irreversible Electroporation (IRE), Drug: Gemcitabine, Drug: FOLFIRINOXIrreversible electroporation and treatment with either FOLFIRINOX or Gemcitabine (based upon which chemotherapy regimen received prior to IRE) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- greater than or equal to 18 years of age
- diagnosed with stage III pancreatic cancer
- tumor is measurable
- GFR > mL/min/1.73m2
- willing and able to comply with protocol requirements
Key exclusion criteria (5 listed)
- participating in another clinical trial for the treatment of cancer at the time of screening
- pregnant or currently breast feeding
- have a cardiac pacemaker or ICD implanted that cannot be deactivated during IRE procedure
- have non-removable implants with metal parts within 1 cm of the target lesion
- had a myocardial infarction within 3 months prior to enrollment
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 |
|---|---|---|
| Irreversible Electroporation (IRE)Non-thermal ablation of tumor | Procedure or surgery | Treatment |
| Gemcitabine25% dose - first 3 enrolled; 50% dose - next 3 enrolled; 75% dose - remaining 4 enrolled | Drug | Treatment |
| FOLFIRINOX25% dose - first 3 enrolled; 50% dose - next 3 enrolled; 75% dose - remaining 4 enrolled | Drug | Treatment |
Primary outcome
Incidence of Adverse and Serious Adverse events will be captured (safety and tolerability)
Time frame: Time from first dose until subject has reached 90 days post last active study treatment
Adverse and Serious Adverse events will be collected and analyzed
1 secondary outcome
Progression free survival
Time frame: Time from first dose date to first date of confirmed disease progression, assessed for 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Derived from this study: PubMed 32681477Bhutiani N, Li Y, Zheng Q, Pandit H, Shi X, Chen Y, Yu Y, Pulliam ZR, Tan M, Martin RCG 2nd. Electrochemotherapy with Irreversible Electroporation and FOLFIRINOX Improves Survival in Murine Models of Pancreatic Adenocarcinoma. Ann Surg Oncol. 2020 Oct;27(11):4348-4359. doi: 10.1245/s10434-020-08782-2. Epub 2020 Jul 17.
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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.
Robert Martin, MD, PhD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Irreversible Electroporation (IRE), Gemcitabine and FOLFIRINOX in people with Pancreas Cancer, run by University of Louisville 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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 29 Oct 2025. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Martin, MD, PhD (502-629-3355, robert.martin@louisville.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse and Serious Adverse events will be captured (safety and tolerability) (time frame: Time from first dose until subject has reached 90 days post last active study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03484299, which also lists 1 linked publication.
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 29 Oct 2025.