Irreversible Electroporation for Pancreatic Cancer

(SMART Trial)

Recruiting at 1 trial location

Overseen By Shahid Ahmed, MD, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Saskatchewan

Must be taking: Chemotherapy

Disqualifiers: Pregnancy, Metastatic cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

27 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment method for individuals with locally advanced pancreatic cancer. Researchers are testing irreversible electroporation (IRE), a non-thermal ablation technique designed to control the disease without harming nearby tissues. Participants will receive combination chemotherapy, and if effective, they will also undergo IRE. The goal is to determine if this combination can extend patients' lives without cancer progression. Individuals with non-metastatic pancreatic cancer who are eligible for chemotherapy might be suitable candidates for this study. As an unphased trial, this study provides patients the opportunity to contribute to innovative research that could lead to new treatment options.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with your doctor or the trial coordinators.

What prior data suggests that irreversible electroporation is safe for treating pancreatic cancer?

In earlier studies, irreversible electroporation (IRE) has shown promise for treating pancreatic cancer. Research suggests that IRE carries a low risk of side effects, with safety comparable to standard treatments. For instance, one study found low death rates within 90 days after the procedure, indicating relative short-term safety.

However, some complications, such as abdominal bleeding and blood vessel issues, have been reported. While important to consider, these complications have not been common. Overall, IRE appears to be a well-tolerated option for patients, with manageable risks when performed carefully. It is crucial to discuss potential risks and benefits with a healthcare provider before deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Irreversible electroporation (IRE) for pancreatic cancer is unique because it uses electrical pulses to create tiny holes in cancer cell membranes, causing the cells to die without damaging surrounding healthy tissue. This is different from most current treatments like chemotherapy and radiation, which can affect both cancerous and healthy cells. Researchers are excited about IRE because it offers a targeted approach that could lead to fewer side effects and potentially improve outcomes for patients with this challenging type of cancer.

What evidence suggests that irreversible electroporation is effective for locally advanced pancreatic cancer?

Research has shown that irreversible electroporation (IRE) is a promising treatment for advanced pancreatic cancer. IRE breaks the outer layer of cancer cells, killing them while leaving nearby blood vessels and tissues unharmed. In this trial, all eligible patients will receive combination chemotherapy, and if they respond positively, they will undergo IRE. One study showed that using IRE with chemotherapy significantly slowed cancer growth. Another study found that patients who received IRE lived longer than those who only had chemotherapy. Although more research is needed, these findings suggest that IRE could be a valuable addition to current treatment options. ^{3 6 7 8 9}

Who Is on the Research Team?

Shahid Ahmed, MD, PhD

Principal Investigator

University of Saskatchewan

Are You a Good Fit for This Trial?

This trial is for adults with locally advanced pancreatic cancer that hasn't spread, who can handle combination chemotherapy. It's not suitable for those whose tumors are too big or have other conditions making them ineligible.

Inclusion Criteria

I have advanced pancreatic cancer and am eligible for chemotherapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Chemotherapy

Participants receive 12 weeks of induction chemotherapy with FOLFIRINOX or Gemcitabine plus nab-paclitaxel

12 weeks

Regular visits for chemotherapy administration

IRE Procedure

Participants undergo IRE if eligible after induction chemotherapy

1 week

1 visit for IRE procedure

Continuation Chemotherapy

Participants receive an additional 12 weeks of chemotherapy post-IRE

12 weeks

Regular visits for chemotherapy administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Follow-up visits every 2-3 months

What Are the Treatments Tested in This Trial?

Interventions

• Combination chemotherapy
• Irreversible electroporation (NanoKnife® )

Trial Overview The study tests if irreversible electroporation (IRE), a non-thermal ablation technique, combined with chemotherapy improves survival in pancreatic cancer patients compared to chemotherapy alone.

How Is the Trial Designed?

Group I: Single arm study Experimental Treatment 1 Intervention

All eligible patients will receive combination chemotherapy and if there i s a positive response they will undergo IRE.

Who Is Running the Clinical Trial?

University of Saskatchewan

Lead Sponsor

Trials

261

Recruited

156,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11640091/

Initial Results from the DIRECT Registry Study - PMC Irreversible electroporation (IRE) is a local tumor ablation method that induces cancerous cell death by disrupting cell membrane homeostasis.

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.e16301

Effectiveness and safety of irreversible electroporation ... The present study was designed to assess the effectiveness and safety of IRE for Stage 3 PDAC in a real-world setting after induction chemotherapy.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10002122/

Irreversible Electroporation in Pancreatic Cancer—An ... According to the data presented by Bhutiani et al., 2020 [24], the use of stand-alone IRE results in a two-times decrease in the proliferation ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2210261217304443

Irreversible electroporation for locally advanced pancreatic ... In a 2014 systematic review of 4 studies reporting on the use of IRE to treat 74 patients with advanced pancreatic cancer [11], morbidity, including bile and ...

5. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-021-08474-4

Multicenter randomized controlled trial and registry study to ... Median overall 5-year survival for patients with Stage 1 and 2 pancreatic cancer has been reported to be 24.4 months while locally advanced ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9688427/

Safety and Efficacy of Irreversible Electroporation in Locally ... Irreversible electroporation (IRE) has emerged as a promising treatment for patients with locally advanced pancreatic cancer (LAPC).

7. bmcsurg.biomedcentral.com bmcsurg.biomedcentral.com/articles/10.1186/s12893-025-03136-9

Real-world safety of irreversible electroporation therapy for ... In pancreatic cancer, abdominal hemorrhage and vascular pseudoaneurysms were observed in the IRE group, and these complications were directly ...

8. mdpi.com mdpi.com/2072-6694/16/23/3894

Effectiveness and Safety of Irreversible Electroporation ... This preliminary analysis of data from the study demonstrates IRE can be performed safely with low toxicity and favorable 90-day mortality similar to SOC ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT03899649

A Registry Study of NanoKnife IRE for Stage 3 Pancreatic ... This multicenter, observational study will evaluate the effectiveness and safety of the NanoKnife System when used for the ablation of Stage 3 pancreatic ...